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Regulatory Affairs (245) See Also:
Sites:
» 1A-Food Consulting
 European regulatory affairs company specialized in food safety assessment, food supplements, and European food legislation. http://www.1a-food.eu » ADN
Compliance for electronic record management for FDA regulated companies. http://www.adneurope.com » AQA Co.
Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available. http://www.isoxp.com/ » ARX
21 CFR Part 11 compliant digital and electronic signatures for any file format, document system, or web application. http://www.arx.com » ARx Pharma, Inc.
Provide scientific and regulatory CMC consulting services to the global pharmaceutical and biopharmaceutical industry through strategic design and implementation of different aspects. http://www.arxpharma.com/ » ASG Inc.
Clinical Consulting: Specializing in regulatory affairs, sas programming, biotechnology careers, data management companies, staffing pharmaceutical, consulting, statistics, biotechnology, sas, and cro. http://www.asg-inc.com » Abnovo Ltd
Specialize in regulatory consulting and authorized representation in the European Union. http://www.abnovo.eu » Accurate Consultants
FDA compliance and regulatory consulting to help clients develop efficient and effective quality systems. http://www.accuratefdaconsulting.com » Acerna Inc.
GMP consultancy in Canada, assisting global pharmaceutical, biological, medical device, natural health products, and cosmetics companies with manufacturing or regulatory compliance issues. http://www.acerna.ca » Aclairo
Aclairo is a drug development consultancy, based in the Washington DC area, focusing on preclinical toxicology, pharmacology, regulatory affairs issues, and U.S. Agent services to non-U.S. biopharmaceutical companies. http://www.aclairo.com » Aexelar Regulatory Experts
Consortium of pharmaceutical regulatory affairs consulting services. http://www.aexelar.com » Aitheras, LLC.
Offers validation, ERP/CRM, testing, and enterprise efficiency services for medium and large scale organizations from Rockville, Maryland. http://www.aitheras.com/ » Al Weisenborn Medical Device Consulting
Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services. http://www.qsrhelp.com » Alenpharm
Offering qualified services for the initial registration and re-certification of medical supplies, biologically active additives, and medications to sellers and manufacturers of these products. http://www.alenpharm.com » Alphapharma Consulting
Good Manufacturing Practice (GMP) consulting services to the pharmaceutical industry. http://www.alphapharma.com/aboutus.html » American Technical Consultants
Consultant group specializing in providing services on FDA compliance issues to the food, drug and cosmetic industry. http://www.atccorp.net/ » Applied Regulatory Consulting Ltd
Provides European regulatory consultancy to the pharmaceutical industry, including strategic regulatory consultancy, training, regulatory agency interactions, and regulatory submissions. http://www.europeanregulatory.com » Arham Consultants.com
Pharma regulatory affairs consultants based in New Delhi, India for the department of DCGI - Drugs Controller General of India - and NPPA - National Pharmaceutical Pricing Authority. http://arhamconsultants.com » Arvin Shroff Associates LLC
Advisor to pharmaceutical, biotechnology, medical device, food, dietary supplements, and legal companies. http://www.arvinshroff.com » Atubra Inc.
Atubra provides a full range of consulting services to FDA regulated industries including drug, medical device, cosmetic, and dietary supplement companies. http://atubra.com » Azilon Corporation
Provides compliance solutions for healthcare and financial sectors. http://azilon.com » BNA consultants
Specialize in regulation of natural health products, health supplements, foods, pharmaceuticals, and cosmetics. http://www.gbnac.com » Barnhill & Associates, Inc.
A specialty based consulting firm specializing in a range of scientific, laboratory, quality, and validation issues within the cGMP and GLP arena. http://barnhillassociates.net » Becker Compliance
Provides Quality System and compliance consulting services. http://www.becker-compliance.com » BesTech
Consulting services guides medical companies through the FDA and CE compliance processes to ensure their business success. Provide solutions for regulatory compliance, product safety, litigation support and design and development of medical devices. http://www.bestechconsulting.biz » Biologics Consulting Group
FDA regulatory experience and provide regulatory application support, "mock" FDA inspections, vendor and clinical trial site audits, statistical services, clinical trial design/review, and preparation of responses to FDA compliance actions. http://www.biologicsconsulting.com » Biotech Consultant LLC
Biotech Consultant LLC provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, microarrays, pharma http://www.biotech-consultant.com » Biotechnology Consulting Solutions, Ltd.
Consulting services in regulatory affairs (including GLP and cGMP) for the development of biologicals, pharmaceuticals, and diagnostics. http://www.biotechconsultsolns.com » BrainWeaver, LLC
Online HIPAA training and compliance do-it-yourself kits. http://www.hipaatraining.com » Brandt Research Consulting LLC
Providing a wide range of consulting services in GCP, GLP and GMP compliance. http://www.brandtconsulting.us » Buphycon Consultancy
Provide scientific and regulatory affairs consultancy to investors, individual investigators, and the biopharmaceutical industry operating in the field of vaccinology. http://www.buphycon.com » CATS Consultants GmbH
EU regulatory affairs and preclinical/toxicological consulting. http://www.catsconsultants.com » CIEX, Incorporated
CIEX Incorporated is dedicated to Quality Software and provides services in Software Lifecycle Processes, Software Quality Assessments, Reliable Software Design. http://www.ciexinc.com » CIMCON Software, Inc.
Document, drawing and spreadsheet management solutions for US FDA compliant pharma manufacturing units. http://www.part11solutions.com » CL Tech Inc.
Provide qualification, compliance, regulatory, training, and validation services to pharmaceutical, medical device, and biotechnology industries. Specializing in facility, equipment and Part 11 validations. http://www.qualityleader.com » CLINSTEP LLC
Multilingual regulatory affairs consultancy for medical devices, pharmaceuticals and diagnostic devices. http://www.clinstep.com » CMAC Consultancy
Provides services like documentation and change control, validation and qualification execution, calibration and preventive maintenance, GXP training and implementation, project administration and commissioning, as well as, IT services/operation managemen http://www.cmacusa.com » Cabridge Regulatory Services
Specialists in the field of pharmaceutical regulatory affairs. http://www.cambreg.co.uk » CanReg Inc.
Regulatory specialists provide strategy, submissions, and support for global clients. http://www.canreginc.com » Carexa Inc.
Consultants providing strategy and services for drug development and regulatory affairs. http://www.carexa.com » Certified Compliance Solutions
CCS is a software and process verification and validation provider for the medical device and pharmaceutical industries. http://www.certifiedcompliance.com » Ceutical Labs
Provide infrastructure to small to medium sized businesses in pharmaceutical, medical device, nutraceutical, pet, and cosmetic industries, including product development, project management, validation, quality, regulatory affairs, IT, sales, and marketing http://www.ceuticallabs.com » Chemgineering
German consulting and engineering group with a focal on challenging capital investment projects in the Life Sciences industries. http://www.chemgineering.com » Chestnut Solutions Inc.
Offers global regulatory strategies, document management, electronic submissions and CTD filings to pharmaceutical and biotech companies and contract research organizations in Canada, Europe and the US. http://chestnutsolutions.com/ » Clinical Device Group Inc.
Clinical Device Group offers full CRO services for medical devices manufacturers. http://www.clinicaldevice.com » Coastal Consulting Group, Ltd.
Medical device regulatory affairs, clinical studies, quality systems, and documentation services. http://www.coastalcg.com » Coda Corp. USA
Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide. http://www.codacorpusa.com/ » Coding Compliance Solutions
Consulting firms specializing in supporting hospitals, physicians and attorneys address complex coding issues. Major emphasis on working with counsel in support of fraud and abuse allegations from third-party payers. http://codingcompliance.com » Compli
A commissioning, validation, cGMP, and regulatory compliance consulting services company. http://ucompli.com » CompliaPharm, LLC
Quality and regulatory compliance consulting services for the life sciences industry. http://www.compliapharm.com » Compliance Associates
Dedicated to providing the Life Science industry with solutions to complex regulatory and business critical requirements. http://www.complianceassociates.ca » Compliance Control Ltd.
Provide software products and consultancy expertise to help companies achieve compliant and validated systems. http://www.compliance-control.com » Comply
Software packages for quality assurance processes such as management of the documentation center, employee training records, environmental monitoring, deviations, CAPA, stability studies, and trends analysis. http://www.comply.co.il » Computer System Validation
Consultant involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. http://www.ComputerSystemValidation.com » Cro.nu
CRO in drug development process in close collaboration with the preclinical and clinical departments of pharmaceutical and biotech companies. http://www.cro.nu » Custom Business Development & Management Technology
Assists companies in biotechnology, pharmaceutical and chemical markets with business development and market analysis. http://www.cbdmt.com » Cyton Biosciences Ltd.
European regulatory affairs consultancy providing specialist product development and registration services. http://www.cyton.com » D & D Consulting LLC
D & D Consulting LLC provides validation, commissioning, and quality services to the pharmaceutical, biotechnology, and medical device industries. http://www.ddcvalidation.com » DRW Research & Information Services, LLC
Provides regulatory affairs research and information for the healthcare industry. http://www.drw-research.com » Delphi Consulting
Delphi Consulting Group provides US FDA consulting services for medical devices. http://www.delphiconsulting.com » Di Renzo Regulatory Affairs
Provides regulatory services for human and veterinary medicines, mutual recognition, cosmetics, foods, medical devices, and translations. Rome, Italy. http://www.direnzo.biz » Diapharm
German consulting firm assists pharmaceutical and healthcare companies with regulatory matters relating to drugs, medical products, nutritional supplements, biocides, and cosmetics. http://www.diapharm.com » Doctor Device
Consultant for medical device importers, manufacturers, and physicians intending to introduce medical devices into U.S. commerce. Expert witness for neurological devices. http://www.doctordevice.com/ » Draco Associates Ltd.
Draco Associates offers regulatory affairs consulting and quality assurance consulting and services for pharmaceuticals, natural health products, and other regulated products. http://www.dracoassociates.com » ERA Consulting Group
Specialist services for pharmaceutical companies in regulatory affairs, including the development/registration of biotechnology and biological medicinal products, with offices in Europe and the United States. http://www.eraconsulting.com » EZ Risk Management
ISO 14971 risk management software system for compliance with ISO 14971:2007. http://www.EZRiskManagement.com » Ehrreich Consulting, Inc.
Regulatory consultants expediting FDA approval by solving tough scientific, clinical, and regulatory issues which may arise pre- and post-submission. http://www.regsolutions.com » Emergo Group, Inc.
Consultants to medical device companies for CE marking, authorized representative, FDA compliance and CCC mark for China. Offices in US, Europe and Asia. http://www.emergogroup.com » Entrinsik
Their employee development solutions provide for compliance management and learning management; our Gxp compliance Edition is "validation ready", ideal for GxP compliance training requirements in the pharmaceutical or medical device industries. http://www.entrinsik.com » Estrin Consulting Group, Inc.
ECG serves the medical device, pharmaceutical and cosmetic firms on FDA submissions, meetings and compliance related issues. Founder and President: Norman F. Estrin, Ph.D. Regulatory Affairs Certified. http://yourfdaconsultant.com/ » Evolve Technologies, Inc
Provide online privacy and security HIPAA training for business associates, employers, hospitals, clinics and health plans. http://www.ehipaatraining.com » FDA Compliance Solutions
Consultants providing a full range of FDA compliance services, including computer system validation, software validation, process validation, pharmaceutical validation and consulting. http://www.fdacompliancesolutions.com » FDA Consulting Services
Service companies in the pharmaceutical industry, bio-technology, and medical device industries. http://xfdapros.com » FDALive.com
Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CDs, videotapes and transcripts available. http://www.fdalive.com/ » FDC Services, LLC
A regulatory affairs and quality systems consulting company serving the medical device and pharmaceutical industries. http://fdcservices.com » FarmavitaR+
Professional network of regulatory affairs consultants and professionals. http://www.farmavitar.com » Flaig Pharma Consulting
Consultant to the pharmaceutical industry in Germany and other European countries specialized in European drug registration procedures, CMC documents, CTAs, and product maintenance activities. http://flaig-pharma-consulting.de » Ford and Associates
Quality management experience in the medical device manufacturing with a focus on global regulatory compliance. http://www.myfordassociates.com » Fulcrum Pharma
European consultancy with experience in all aspects of regulatory affairs and pharmacovigilance. http://www.fulcrumpharma.com/ » GCP Auditing Services
An independent consultancy providing auditing services for all aspects of clinical trials and good clinical practice. http://www.gcp-auditing.co.uk/ » GCP Solutions
GCP Solutions provides good clinical practice consulting services. http://mysite.verizon.net/sisbill1/gcp.htm » GLP Quality Consulting, LLC
Consulting services for the pharmaceutical, biotech, and agricultural chemistry industries. http://www.glpqualityconsulting.com » GMP Online Consultancy
European-based, Good Manufacturing Practice (GMP) online consultancy. http://www.gmp-online-consultancy.com » GMP Quality Up
Downloadable standard operating procedures and manuals on quality assurance, quality control management, process validation, microbiology testing, regulatory audits, manufacturing, warehouse, occupational health and safety. http://www.gmpqualityup.com » Gallandeer Ridge Pty Ltd
Regulatory consultants to the pharmaceutical and medical device industry in Australia and New Zealand. http://www.grpharmareg.com » Global Quality Alliance, LLC
Team of GMP consultants and quality auditors that provide consulting, auditing, and training to the pharmaceutical, biotechnology, API, dietary supplement, pharmaceutical compounding, and medical device industries. http://www.gqaconsulting.com » Global Regulatory
Pharmaceutical, medical device, biotechnology, food, and nutraceutical consulting for the international markets. http://www.globalregulatory.com/ » Global Regulatory Services
Regulatory affairs services for the pharmaceutical, herbal, and biotech industries. http://www.globalregulatoryservices.com » GxP Medical Writing, LLC
A medical communications company for scientific/medical editing and writing services. http://gxpwriting.com/Home_Page.html » HDM Corp.
Offers Internet-based HIPAA privacy and confidentiality training software for payers, providers and academia as well as HIPAA-compliant medical billing software for providers. http://www.hdmcorp.com » HIPAA Exams, Inc.
Online HIPAA training course and testing for healthcare professionals. http://www.hipaaexams.com » Harpaz Consulting Services
Providing GMP compliance consultation, regulatory and technical expertise to manufacturers of drug products, active pharmaceutical ingredients, and medical devices worldwide. http://www.harpazconsulting.com/ » IDEC Validation Ltd
Provider of Quality and Compliance services to the Pharmaceutical / Biotechnology sector. Primarily assist organisations in the CSV field satisfy Regulatory and Compliance requirements. IVL has field knowledge in the implementation of compliance solutions http://www.idecvalidation.com/ » IHL Consulting Group, Inc.
FDA consultants based in Atlanta Georgia for the drug, biotechnology, biologics, and medical device industries. http://www.ihlconsulting.com » IMI Consulting GmbH
IMI Consulting GmbH is specialized in advising and implementing: strategy development, global marketing, business development, licensing, and mergers and acquisitions. http://www.imiconsulting.com » IPMB GmbH
Institute for regulatory affairs and pharmaceutical services located in Germany. http://www.ipmb.eu/ » ISOMillennium Inc.
Assist in meeting regulatory obligations and minimizing liability risks. http://www.isomillennium.com » Independent Pharma Consultants
Independent Pharma Consultants is a UK based regulatory affairs consultancy that offers a range of services. http://www.ipcons.co.uk » Inflexxion, Inc.
Turnkey solution for risk management needs that integrates sensitive surveillance with sophisticated signal detection, signal verification, and targeted prevention and intervention programs. http://www.navippro.com » Infonetica
GCP online training course provides a comprehensive guide to the basic principles, regulations, and guidelines of ICH good clinical practice. http://www.gcptraining.org.uk » Innovative Automation
Part 11 compliance software solutions designed for MS-Excel, MS-Word, electronic laboratory notebook, and file replication. http://www.21cfrpart11compliance.com/ » Innovative Consultancy Services
Indian pharmaceutical consultant company providing services in regulatory affairs, pharmaceutical dossiers, product/process development, and validation services. http://www.pharmaceutical-consultancy.com » International Regulatory Business Consultants, L.L.C.
Providing scientific and regulatory consultant services to the global pharmaceutical, nutritional supplement, medical device, and diagnostic product industries http://irb-c.com » Japan MDC
Regulatory consulting firm for international medical device companies interested in expanding their market penetration in Japan. http://www.j-mdc.com/ » Jim Colyn & Associates Quality Consultants, LLC
Consulting services targeting compliance and performance for human tissue processors, tissue recovery organizations, organ procurement organizations, eye banks, reproductive banks, and medical device manufacturers. http://www.jcolynconsulting.com » Joe Schwoebel, BSEE, MBA
Offers consulting services related to product planning, clinical study, regulatory affairs and reimbursement strategy. Includes resume, certifications and press releases, and FDA approvals. http://www.schwoebel.net » Jouhou Koukai Services LLC
Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market. http://www.jouhoukoukai.com » KRM Associates
Regulatory due diligence advisory practice for the health care industry specialized in domestic & international regulatory requirements for medical products (e.g. medical devices, pharmaceutical, tissue products, and in vitro diagnostics). http://www.krm-associates.com/ » Kamm & Associates
Specializes in assisting businesses with compliance of GMP/QSR regulations. http://www.fda-consultant.com » Karandikar Laboratories Pvt. Ltd.
Test and calibration laboratory located in India. http://www.laboratorytestingindia.com » Karlton CMC Consulting
Specializing in pharmaceutical CMC regulatory affairs providing long range strategic planning, technical writing, and in-house regulatory affairs training. http://www.karltoncmcregulatory.net » Kemic Bioresearch
Kemic Bioresearch provides consulting, research and training in the pharmaceutical sciences (pharmacokinetics, pharmacology and toxicology). http://www.kemic.com » Kennedy Writing Service (KWS)
Medical writing and proofreading company. http://www.kennedywritingservice.com » Kobridge Consulting Ltd
Korean consultants to medical device companies for CE marking, Canadian approvals, and FDA compliance. http://www.kobridgeconsulting.com » Lachman Consultants
Offers consultancy services to prevent and resolve compliance problems and to develop strategies for the submission and approval of drugs, biologics, and devices. http://www.lachmanconsultants.com » Leonard T. Flynn
An independent regulatory and scientific consultant who provides assistance to pharmaceutical, health product and chemical manufacturers for them to meet the requirements of government agencies. http://www.drflynnconsulting.com » Lewis CMC Consulting
Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services. http://www.lewiscmc.com » Lionpharm Regulatory Consulting GmbH
Lionpharm is an independent consultancy company providing all kind of regulatory affairs services covering the whole life-cycle of medicinal products in Europe. http://www.lionpharm.com » Lorenz LIfe Sciences
Regulatory affairs eCTD software and service for electronic submission management for companies with USA FDA, Canada, Europe, EMEA, Japan PMDA agencies. http://www.lorenz.cc » MDI Consultants. Inc.
A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries. http://www.mdiconsultants.com » MEDIcept
MEDIcept is a vertically integrated consulting firm specializing in contract engineering, quality assurance, and regulatory consulting. http://www.medicept.com » Mandell Horwitz Consultants LLC
Regulatory and scientific consulting for medical devices and other FDA-regulated products. http://mandellhorwitzconsulting.com » MarcM Consulting Canada
Regulatory affairs consultants assisting pharmaceutical and related industries with product registrations, GMP inspections, ISO conformity, clinical research/trials, bioequivalence studies, and DMF preparations. Regulatory and business development service http://www.marcmconsulting.ca » Marion Weinreb and Associates, Inc.
Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs. http://gmpsrus.com » Masy Systems
Validation and calibration services for the pharmaceutical, biotech, and related fields. Information on equipment and shipper studies. http://www.masy.com/ » Med Device Advisors
Offer FDA compliant medical device standard operating procedures (SOP) for sale. Customization service is also available. http://www.meddeviceadvisors.com » Med Pharma Solutions, LLC
Provides on-site compliance consulting services including factory acceptance testing, commissioning, IQ/OQ/PQ's, validation and qualification services to the FDA regulated industries. http://medpharmasolutions.com/ » Medcon Taiwan, Inc.
A Taiwan-based regulatory affairs consultant to the medical and life science industry http://www.medcon-taiwan.com » Medical Device Consultants
Located in the Toronto, Ontario (Canada) region. http://www.medicaldeviceconsultants.ca » Medical Device Consultants, Inc. (MDCI)
Provides worldwide regulatory, clinical, and quality assurance consulting services to medical device and diagnostic product manufacturers to meet US, Canadian, and European requirements. http://www.mdci.com » Mediqol
Offers a range of medical device consultancy services throughout Europe (including CE marking, regulatory and clinical trials management). http://mediqol.com » Medius AG
Consulting and service company based in Switzerland, engaged in regulatory affairs of pharmaceuticals, medical devices, and in vitro diagnostics. http://www.medius-ag.ch » MundoMed
MundoMed is a consultancy based in Holland which specializes in CE-marking medical devices in Europe. http://www.mundomed.nl » NJK & Associates, Inc.
NJK & Associates are a collaborative group of industry consultants serving the medical device and IVD industry. http://njkconsulting.com  » Nigerian Food and Drug Regulatory Advisor
Blog provides information, guidelines, and news about current regulatory matters in the food, drug, medical device, cosmetic, packaged water, and chemical sector of the Nigerian economy. http://www.nigerianfoodanddrugregulatoryadvisor.blogspot.com » OMSBAR
OMSBAR provides consultancy services in regulatory affairs, product registrations, export certification, training, project management and product development, quality management, verification and validation, and maintains a core staff of experienced medic http://www.omsbar.com/ » OSHA Medical Consultants
Provides clinical practice compliance (OSHA, CLIA, CMS & HIPAA) assistance including medical operations matters and clinic/laboratory construction. http://www.oshamedical.com » Obelis European Authorized Representative Center
Offers CE marking, US agent services to non-European medical devices manufacturers under AIMD, MDD, and IVD, under EU directives from Brussels, Belgium. http://www.obelis.net/ » Octagon Research Solutions, Inc.
Offers a suite of services that span the entire clinical research and development lifecycle. http://www.octagonresearch.com » Oracle Consulting Group
Consultants for FDA and internationally regulated medical device firms, specializing in submissions, compliance, warning letter responses, inspection responses, quality system compliance, auditing and training http://www.fdamaze.com » PAT toolkit
Provides information on the FDA’s Process Analytical Technology (PAT) Initiative and outlines a software package to help pharmaceutical manufacturers implement this initiative. http://www.pattoolkit.com » PH PharmAnalysis GmbH
Consultancy based in Germany that offers scientific and regulatory services for the pharmaceutical industry. http://www.pharmanalysis.de » PRISYM ID Compliant Barcode & Labeling
21 CFR Part 11 validated barcode and labeling solutions for pharmaceutical and medical device manufacturers. http://www.prisymidinc.com » PSF Medical
European business support and authorised representative for small medical device companies. http://www.psfmedical.com » Paul Regulatory Services Limited
A regulatory affairs consultancy based in the UK. http://www.paulrs.co.uk » Pennington Pharmaceutical Services LLC
Regulatory compliance solutions targeted for small-to-medium sized pharmaceutical companies. http://www.ppspharmrx.com » Perfect Consultants
Association of consultants engaged in providing regulatory support to Pharmaceutical and Active Pharma Ingredients (API) industries. http://www.perfect-consultants.com » Perkins and Perkins
FDA consultants Perkins and Perkins, Inc. conduct mock FDA audits to insure Good Clinical Practice (GCP) compliance, quality assurance and FDA audit preparation. http://www.perkinsandperkins.net » Perseus Partners
Consulting group headquartered in Belgium. They manage biosafety and biotechnology compliance requirements. http://www.perseus.be » PharmAssure
Australian pharmaceutical consulting services for validation and FDA and TGA GMP/GLP compliance. http://www.pharmassure.com.au » Pharma-EU s.r.o.
Provides consulting services to pharmaceutical regulatory affairs professionals in the European Union. http://www.pharma-eu.com » PharmaCon GmbH
Consulting in regulatory strategy for medicinal products. http://www.pharma-con.ch/ » PharmaReady
PharmaReadyâ„¢ is a fully integrated web-based eDMS and eCTD Submissions Solution Suite. http://www.pharmaready.com/ » Pharmaceutical Development Group
Dr. Cheryl Blume and staff provide pharmaceutical and FDA regulatory consulting services including, but not limited to, development of pharmacovigilance assessment programs, pharmacokinetic protocols, non-clinical protocols and preparation for GCP/GLP and http://www.pharmdevgroup.com » Pharmaceutical Regulatory Services, Inc.
Provide clinical and regulatory support of all phases of global drug development with operations in over 80 countries on all continents. http://www.pharmregservices.com » Pharmacovigilance
Consultancy based in Italy that offers scientific services and regulatory affairs for the pharmaceutical industry. http://www.pharmacovigilanceunit.com » Pharmalink Consulting
For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC http://www.pharmalinkconsulting.co.uk » Pharmareg Consulting Limited
United Kingdom based regulatory consultancy. http://www.pharmaregconsulting.co.uk » Phoenix Regulatory Associates, Ltd
Regulatory affairs consultants based in the Washington DC metro area with the industry and FDA expertise to aid small to large pharmaceutical and medical device companies. http://www.phoenixrising.com » PinneyAssociates
Pinney Associates brings science and public health expertise to pharmaceutical, consumer healthcare, and biologics clients in risk management, over-the-counter switch, and marketing strategy. http://www.pinneyassociates.com/ » PrisymID Life Sciences
Validated labeling systems and inventory management software systems designed specifically for FDA 21 CFR Part 11 regulated environments. http://www.prisymls.com » Q-NET LLC
EU authorized representative service in accordance with the EU medical device directive and EU machinery directive. Also act as FDA US agent for foreign establishments. http://www.ce-authorizedrepresentative.eu » QMR, LLC
Medical device, pharmaceutical, diagnostic, and other life science quality assurance and regulatory affairs consulting services. http://www.qmr-llc.com » QRC Associates
QRC Associates provides management with cGMP and QSR advice. http://www.qrcassociates.com » QSite
Qsite is a consulting group focused on the medical device industry. Services include advice on international regulatory affairs, clinical affairs, biostatistics, and global quality assurance. http://www.qsitemed.com » Qarad
Specializing in CE marking, services for medical devices and also for manufacturers of personal protective equipment, in vitro diagnostics and medical test laboratories. http://www.qarad.com » Qserve Group
Qserve® Group B.V provides CE Marking, quality management system implementation and auditing of ISO 13485, (pre)clinical evaluation, product market approval (e.g. CE/EU and FDA/USA) and production registration as well as other regulatory services. http://www.qservegroup.com/ » Quadras
Service partner for international approval, registration, listing, and certification of medical devices in Europe, Asia, America, and Australia. http://www.quadras.de » QualiMedd
An independent UK management consultancy working within the areas of product development specializing in medical devices and in-vitro diagnostics. http://www.qualimedd.com » Quality First International Ltd.
QFI is a European based consultancy providing CE marking services, EU Authorised Representative Programme, Microbiology Advisory Programme, QMS implementation, Conformity Assessment support and compliance audits http://www.qualityfirstint.com » Quality Implementation Services Inc.
Provides consulting services to pharmaceutical, medical device, and life sciences industries in quality assurance, quality control, and regulatory affairs compliance. http://www.qisfdaconsultants.com » Quality Medical Regulations Services
Provides quality assurance documentation support. Assists in site licensing, product registration, HACCP development and implementation. Ottawa, Canada. http://www.qmrs.com/ » Quality Solutions
Validation Professionals, Inc. (VPI) offers a full range of validation, compliance and technical services for the pharmaceutical, biotechnology and medical device industries. http://www.validationprofessionals.com » Quality Systems Laboratories
Provides compliance process management and eLearning products and services. http://www.qslabs.com » Quality Vectors
Provide validations, cGxP compliance, systems engineering, and quality systems to pharmaceutical, medical device, and biotechnology industries. http://www.quality-vectors.com » Qware Riskmanager
A management system for the risk analysis for producers of medical devices and in-vitro-diagnostics according to the world wide valid standard DIN EN ISO 14971. http://www.risk-online.com » R. A. Q .A. Associates
R.A.Q.A. Associates provides FDA and ISO related consulting services to medical device and pharmaceutical companies. We specialize in helping firms with regulatory and cGMP problems, constructing and implementing entirely new quality and regulatory system http://www.raqaassociates.com » RegIntel Ltd.
Provides international regulatory solutions to the pharmaceutical and biologics industries. http://www.regintel.com » Regulatory Affairs Consulting
Regulatory affairs consulting services to the pharmaceutical and related industries. http://www.newdrugapprovals.com » Regulatory Affairs, North America LLC
Regulatory affairs consultancy headquartered in North Carolina. http://www.ranallc.com » Regulatory Bureau "Cratia"
Consulting and active assistance in registration (regulatory affairs) and clinical trials of medicinal products, API's, supplements, and medical devices in CIS countries (Ukraine, Russian Federation, Kazakhstan, Moldova, Byelorussia). http://www.bureaucracy.com.ua » Regulatory Pharma
Regulatory Pharma provides regulatory affairs consultancy services (registration and reimbursement of medicinal products (Rx, OTC, plant origin), medical devices, food supplements, and cosmetics) in Poland and Romania. http://www.regulatorypharma.com/ » RegulatoryPro.com
RegulatoryPro offers regulatory affairs consulting services to the biopharmaceutical, medical device and other FDA-regulated industries. http://www.regulatorypro.com » SDCS
Consultant and advocate for the medical device industry on issues of regulatory and standards compliance, risk management (ISO 14971) and general device safety. http://devicecompliance.com/ » SMB Validation and Compliance Services Group
SMB Group is designed to get your equipment into production promptly while ensuring that all regulatory requirements are systematically fulfilled with a minimum of interference with operations. http://www.smbvalidation.com/ » Sagaem
Sagaem is an Italian consultancy providing regulatory affairs and business development services to pharmaceutical companies wishing to approach the Italian market or enlarge their existing business in Italy. http://www.sagaem.it » Salamandra LLC
Salamandra LLC provides strategic, technical, and regulatory consulting services to the pharmaceutical industry for drug, biologic, and device development. http://www.salamandra.net » Samarind Regulatory Management Software
Samarind RMS is a software package for the pharmaceutical industry that manages regulatory affairs and licence submissions. http://www.samarindrms.co.uk » Seagull Comm.V - Regulatory Affairs and Quality Assurance Consulting
Seagull Comm.V is a Belgian company that provides consulting services in the fields of regulatory affairs, quality assurance, pricing and reimbursement, pharmacovigilance, and medical writing for medicinal products. http://seagull.eu » SeerPharma
SeerPharma is a professional consultancy specializing in the delivery of technical compliance and validation, QA knowledge, and GMP training solutions to the pharmaceutical, medical device and biotechnology industries. http://www.seerpharma.com.au » Seraphim Life Sciences Consulting LLC
Seraphim provides integrated consulting and due diligence on regulatory and operations issues for life sciences companies and investors. http://www.seraphimlifesciences.com/ » Shafi Consultancy
Firm specializing in providing SAS training and expertise in working with clinical trials. http://www.shaficonsultancy.com/ » Sigma Biomedical
Sigma Biomedical supports biomedical research and medical device development by providing custom solutions. http://www.sigmabiomedical.com » Sindor Healthcare Consulting
Based in Singapore, providing healthcare consulting including regulatory affairs, quality management systems, marketing, and business development. http://www.sindor.com » Smith and Associates
A consulting firm specializing in regulatory affairs for medical device manufacturing. http://www.fdaconsultants.com/ » Spherelink FDA Consulting
Spherelink provides FDA consulting and international trade consulting between Asia and the United States. http://spherelink.com » Strategic Compliance International, Inc.
SCI, Inc. specializes in regulatory compliance consulting for biologics, medical devices and drug companies. http://www.sci-nc.com » Supremus Group
Provides HIPAA training courses in multiple formats both onsite and online. http://www.training-hipaa.net/ » TDC Software
TDC Software is an engineering software suite covering risk management. http://www.tdc.fr/en/products/tdc_fmea.php » THINQ Compliance Ltd.
The integration of services and software to provide competitive compliance, quality advocacy and thought leadership. http://www.thinqcompliance.com/ » TRAC Services
A UK based company providing regulatory affairs consultancy and patient information leaflet user testing to the pharmaceutical industry. http://www.tracservices.co.uk/ » Tarius A/S
Provides the pharmaceutical, biologics and medical device industries with regulatory and compliance information. Includes services provided, company news and events. http://www.tarius.com/ » Tecno-med Ingenieros
Located in Barcelona, Spain - helps manufacturers to obtain CE mark for their medical devices. http://www.tecno-med.es/ » The Gnomon Group, LLC
Regulatory affairs consulting services based in Research Triangle Park NC covering the pharmaceutical and biotech industries, including regulatory strategy, FDA submissions, safety review, foreign company filings, and marketing review. http://thegnomongroup.com » The Horizon Phoenix Group LLC
Quality/regulatory consultants for medical device, pharmaceutical and biotechnology industries. Services include: CE Marking, Authorized European Representative, USFDA, 510ks, PMAs, US Agent and Canadian Licenses. http://www.horizonphoenix.biz » The Matthews Consultancy
European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development. http://www.tmconsultancy.com/ » The Tamarack Group
Tamarack Group consultants (Charmaine Sutton, Carol DeSain) provide regulatory approvals and compliance services (GMP, QSR) for product development and manufacturers of medical products (US FDA, EU, Canada). http://www.thetamarackgroup.net » Thermal Compliance Ltd
Thermal mapping and autoclave validation http://www.thermalcompliance.co.uk » Thomas E. Colonna Ph.D./J.D. & Associates
Provides consulting services in the scientific and regulatory aspects of a wide range of medical devices with particular expertise in the areas of in vitro diagnostics and biotechnology-based products. http://www.tcolonna.com » TopPharm Consulting
Regulatory affairs consultancy in Poland and EU (MRP, DCP, national, medical devices, food supplements, and scientific dossier consultation). http://www.regulatory-affairs.pl/ » Torrington Gower Consultants
Regulatory affairs consultants specializing in CMC/ Clinical National (UK and IE) submissions (renewals and variations). http://www.torringtongowerconsultants.com » Tumont Limited
Specializes in providing cGxP equipment and software validation support to pharmaceutical laboratories in UK. They can provide plans, protocols, reports, SOPs, inventories and training on a fixed cost basis. http://www.tumont.co.uk » Turio Ltd.
European consultancy provides services to the FDA regulated pharmaceutical industry. http://turio.co.uk » UK Medical Device Consultancy
Provides medical device companies with business development services from regulatory affairs, quality systems to strategic reviews, marketing advice, strategic market research, product management from concept to market, business planning, distribution and http://www.medicaldeviceconsultancy.co.uk » Universal Regulatory Inc.
Specializing in regulatory strategy development, preparation, and review of regulatory submissions. http://www.universalregulatory.com » VTS Consultants, Inc.
Validation and regulatory consulting services for the pharmaceutical, biotechnology, and medical device industries. http://www.vtsconsultants.com » Validation Online Net
Generic downloadable documents that are cGMP compliant. http://www.validation-online.net » Validation Systems, Inc.
We provide contract and consulting services in the following areas: validation and technical services (IQ OQ PQ protocols and validation master plans VMP), quality systems development, laboratory services, environmental monitoring, and water testing. http://www.validationsystems.com » Validation Technologies, Inc.
Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries. http://www.validation.org/ » Validation and cGMP Compliance
Equipment and Software Validation. Part 11 of 21 CFR Compliance. Regulations, cGMP, Validation knowledge base. FDA Warning letters. http://www.cqionline.com/ » Validation in Partnership Ltd
Specializing in the provision of validation and CGMP (Current Good Manufacturing Practice) compliance services. http://www.vipltd.co.uk » Wainwright Associates
UK based regulatory affairs consultants offering a wide range of services to international companies in the pharmaceutical, medical device, nutritional and healthcare industry. http://wainwrightassociates.co.uk » Waters Corporation
A resource for issues surrounding the FDA's 21 CFR Part 11 Rule on electronic records and signatures. http://www.21cfrpart11.com » Wolter Kluwers MediRegs
Compliance and risk management software solutions for your business. Specializing in healthcare billing compliance, ERM (enterprise risk management), food, drug and medical device compliance, and grant management compliance. http://www.mediregs.com » Zeta Consulting
Informatics oriented organization involved in multiple validation and implementation projects in the pharmaceutical and clinical trials industries. http://zeta.jo » Zodiac Pharmaceutical Services
Provides consulting services in the areas of patent, regulatory affairs, marketing research, and QA/GMP documentation for small to medium size pharmaceutical companies. http://www.zodiacpharma.com/ » eCTD Office
A suite of three integrated NeeS/eCTD software products for the creation, validation, viewing, manipulation and archiving of NeeS/eCTD submissions. http://www.ectdoffice.com/ » eCTD Software
Resources, advice, and customer reviews to facilitate transition to eCTD software. http://www.ectdsoftware.com » elc group
Regulatory affairs company with its HQ in Prague, Czech Republic assisting pharmaceutical and related industries with product registrations, GMP inspections, medical writing, clinical research/trials, bioequivalence studies. Regulatory services offered al http://www.elc-group.com » reg-info.com
A collection of links to websites with information relating to regulatory affairs, regulatory intelligence, and the regulation of medicines. http://reg-info.com/ » www.delcornosas.com/
Services to the pharmaceutical industry, aimed at obtaining the appropriate authorizations in Italy and Europe. http://www.delcornosas.com/ » xfda consulting
xFDA consulting provides services to small and mid-sized pharmaceutical and device companies including biotechnology in the areas of preclinical, clinical, CMC and regulatory. http://www.xfda.com Category Editor: dctec
Last Updated: 2007-01-02 17:52:42
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