Directory of Regulatory Affairs Resources

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• 1A-Food Consulting

  http://www.1a-food.eu/
  European regulatory affairs company specialized in food safety assessment, food supplements, and European food legislation.

• Abnovo Ltd

  http://www.abnovo.eu/
  Specialize in regulatory consulting and authorized representation in the European Union.

• Abrimed

  http://abrimed.com/
  Regulatory affairs consultants for ISO, GMP, and FDA compliance

• Accurate Consultants

  http://www.accuratefdaconsulting.com/
  FDA compliance and regulatory consulting to help clients develop efficient and effective quality systems.

• Acerna Inc.

  http://www.acerna.ca/
  GMP consultancy in Canada, assisting global pharmaceutical, biological, medical device, natural health products, and cosmetics companies with manufacturing or regulatory compliance issues.

• Aclairo

  http://www.aclairo.com/
  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.

• ADN

  http://www.adneurope.com/index.php?id=2&L=2
  Compliance for electronic record management for FDA regulated companies.

• Aexelar Regulatory Experts

  http://www.aexelar.com/
  Consortium of pharmaceutical regulatory affairs consulting services.

• Aitheras, LLC.

  http://www.aitheras.com/
  Offers validation, ERP/CRM, testing, and enterprise efficiency services for medium and large scale organizations from Rockville, Maryland.

• American Technical Consultants

  http://www.atccorp.net/
  Consultant group specializing in providing services on FDA compliance issues to the food, drug and cosmetic industry.

• Applied Regulatory Consulting Ltd

  http://www.europeanregulatory.com/
  Provides European regulatory consultancy to the pharmaceutical industry, including strategic regulatory consultancy, training, regulatory agency interactions, and regulatory submissions.

• Arazy Group

  http://www.arazygroup.com/
  Medical device consultant providing manufacturers with market approval, clinical evaluation, FDA Clearance as well as evaluation from public health authorities. Offices in London, UK and Buenos Aires. Argentina.

• Arham Consultants.com

  http://arhamconsultants.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.

• Azilon Corporation

  http://s405824064.onlinehome.us/azilon.com/
  Provides compliance solutions for healthcare and financial sectors.

• Biologics Consulting Group

  http://www.biologicsconsulting.com/
  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.

• Biotech Consultant LLC

  http://www.biotech-consultant.com/
  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, pharmacogenomics, analyte specific reagent (ASR) regulatory compliance, and proteomics), medical device software (including bioinformatics), CPT coding reimbursement, and biotechnology-based products.

• BNA consultants

  http://www.gbnac.com/
  Specialize in regulation of natural health products, health supplements, foods, pharmaceuticals, and cosmetics.

• Brandt Research Consulting LLC

  http://www.brandtconsulting.us/
  Providing a wide range of consulting services in GCP, GLP and GMP compliance.

• Cabridge Regulatory Services

  http://www.cambreg.co.uk/
  Specialists in the field of pharmaceutical regulatory affairs.

• CATS Consultants GmbH

  http://www.catsconsultants.com/
  EU regulatory affairs and preclinical/toxicological consulting.

• Certified Compliance Solutions

  http://www.certifiedcompliance.com/
  CCS is a software and process verification and validation provider for the medical device and pharmaceutical industries.

• Ceutical Labs

  http://www.ceuticallabs.com/
  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.

• Chemgineering

  http://www.chemgineering.com/
  German consulting and engineering group with a focal on challenging capital investment projects in the Life Sciences industries.

• Chestnut Solutions Inc.

  http://chestnutsolutions.com/
  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.

• CIEX, Incorporated

  http://www.ciexinc.com/
  CIEX Incorporated is dedicated to Quality Software and provides services in Software Lifecycle Processes, Software Quality Assessments, Reliable Software Design.

• CIMCON Software, Inc.

  http://www.part11solutions.com/
  Document, drawing and spreadsheet management solutions for US FDA compliant pharma manufacturing units.

• CL Tech Inc.

  http://www.qualityleader.com/
  Provide qualification, compliance, regulatory, training, and validation services to pharmaceutical, medical device, and biotechnology industries. Specializing in facility, equipment and Part 11 validations.

• Clinical Device Group Inc.

  http://www.clinicaldevice.com/
  Offers full CRO services for medical devices manufacturers.

• Coastal Consulting Group, Ltd.

  http://www.coastalcg.com/
  Medical device regulatory affairs, clinical studies, quality systems, and documentation services.

• Coda Corp. USA

  http://www.codacorpusa.com/
  Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide.

• Coding Compliance Solutions

  http://codingcompliance.com/
  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.

• Compli

  http://ucompli.com/
  A commissioning, validation, cGMP, and regulatory compliance consulting services company.

• Compliance Associates

  http://www.complianceassociates.ca/
  Dedicated to providing the Life Science industry with solutions to complex regulatory and business critical requirements.

• Compliance Control Ltd.

  http://www.compliance-control.com/
  Provide software products and consultancy expertise to help companies achieve compliant and validated systems.

• Comply

  http://www.comply.co.il/
  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.

• Computer System Validation

  http://www.computersystemvalidation.com/
  Consultant involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.

• Cro.nu

  http://www.cro.nu/
  CRO in drug development process in close collaboration with the preclinical and clinical departments of pharmaceutical and biotech companies.

• Custom Business Development & Management Technology

  http://www.cbdmt.com/
  Assists companies in biotechnology, pharmaceutical and chemical markets with business development and market analysis.

• Cyton Biosciences Ltd.

  http://www.cyton.com/
  European regulatory affairs consultancy providing specialist product development and registration services.

• D & D Consulting LLC

  http://www.ddcvalidation.com/
  Provides validation, commissioning, and quality services to the pharmaceutical, biotechnology, and medical device industries.

• Del Corno e Associati sas

  http://www.delcornosas.com/
  Services to the pharmaceutical industry, aimed at obtaining the appropriate authorizations in Italy and Europe.

• Delphi Consulting Group

  http://www.delphiconsulting.com/
  Provides US FDA consulting services for medical devices.

• Di Renzo Regulatory Affairs

  http://www.direnzo.biz/
  Provides regulatory services for human and veterinary medicines, mutual recognition, cosmetics, foods, medical devices, and translations. Rome, Italy.

• Diapharm

  http://www.diapharm.com/
  German consulting firm assists pharmaceutical and healthcare companies with regulatory matters relating to drugs, medical products, nutritional supplements, biocides, and cosmetics.

• Doctor Device

  http://www.doctordevice.com/
  Consultant for medical device importers, manufacturers, and physicians intending to introduce medical devices into U.S. commerce. Expert witness for neurological devices.

• Draco Associates Ltd.

  http://www.dracoassociates.com/
  Draco Associates offers regulatory affairs consulting and quality assurance consulting and services for pharmaceuticals, natural health products, and other regulated products.

• eCTD Office

  http://www.ectdoffice.com/
  A suite of three integrated NeeS/eCTD software products for the creation, validation, viewing, manipulation and archiving of NeeS/eCTD submissions.

• eCTD Software

  http://www.ectdsoftware.com/
  Resources, advice, and customer reviews to facilitate transition to eCTD software.

• Ehrreich Consulting, Inc.

  http://www.regsolutions.com/
  Regulatory consultants expediting FDA approval by solving tough scientific, clinical, and regulatory issues which may arise pre- and post-submission.

• elc group

  http://www.elc-group.com/
  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 all EU languages.

• Emergo Group, Inc.

  http://www.emergogroup.com/
  Consultants to medical device companies for CE marking, authorized representative, FDA compliance and CCC mark for China. Offices in US, Europe and Asia.

• Entrinsik

  http://www.entrinsik.com/
  Their employee development solutions provide for compliance management and learning management; their Gxp compliance Edition is "validation ready", ideal for GxP compliance training requirements in the pharmaceutical or medical device industries.

• ERA Consulting Group

  http://www.eraconsulting.com/
  Specialist services for biopharmaceutical companies in regulatory affairs, including the development/registration of biotechnology and biological medicinal products, with offices in Europe, United States and Australia.

• Estrin Consulting Group, Inc.

  http://yourfdaconsultant.com/
  ECG serves the medical device, pharmaceutical and cosmetic firms on FDA submissions, meetings and compliance related issues.

• Evolve Technologies, Inc

  http://www.ehipaatraining.com/
  Provide online privacy and security HIPAA training for business associates, employers, hospitals, clinics and health plans.

• Exalon

  http://www.exalon.com/
  Specialized on eCTD submissions.

• EZ Risk Management

  http://www.ezriskmanagement.com/
  ISO 14971 risk management software system for compliance with ISO 14971:2007.

• FarmavitaR+

  http://www.farmavitar.com/
  Professional network of regulatory affairs consultants and professionals.

• FDALive.com

  http://www.fdalive.com/
  Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CDs, videotapes and transcripts available.

• FDC Services, LLC

  http://fdcservices.com/
  A regulatory affairs and quality systems consulting company serving the medical device and pharmaceutical industries.

• Flaig Pharma Consulting

  http://flaig-pharma-consulting.de/
  Consultant to the pharmaceutical industry in Germany and other European countries specialized in European drug registration procedures, CMC documents, CTAs, and product maintenance activities.

• Ford and Associates

  http://www.myfordassociates.com/
  Quality management experience in the medical device manufacturing with a focus on global regulatory compliance.

• Gallandeer Ridge Pty Ltd

  http://www.grpharmareg.com/
  Regulatory consultants to the pharmaceutical and medical device industry in Australia and New Zealand.

• Gamp Forum

  http://www.gampforum.com/
  Bio-Pharma professionals forum.

• GCP Auditing Services

  http://www.gcp-auditing.co.uk/
  An independent consultancy providing auditing services for all aspects of clinical trials and good clinical practice.

• Global Quality Alliance, LLC

  http://www.gqaconsulting.com/
  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.

• Global Regulatory Services

  http://www.globalregulatoryservices.com/
  Regulatory affairs services for the pharmaceutical, herbal, and biotech industries.

• GLP Quality Consulting, LLC

  http://www.glpqualityconsulting.com/
  Consulting services for the pharmaceutical, biotech, and agricultural chemistry industries.

• HIPAA Exams, Inc.

  http://www.hipaaexams.com/
  Online HIPAA training course and testing for healthcare professionals.

• HIPAATraining.com

  http://www.hipaatraining.com/
  Online self paced HIPAA training and compliance do-it-yourself kits.

• IDEC Validation Ltd

  http://www.idecvalidation.com/
  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.

• IHL Consulting Group, Inc.

  http://www.ihlconsulting.com/
  FDA consultants based in Atlanta Georgia for the drug, biotechnology, biologics, and medical device industries.

• IMI Consulting GmbH

  http://www.imiconsulting.com/
  IMI Consulting GmbH is specialized in advising and implementing: strategy development, global marketing, business development, licensing, and mergers and acquisitions.

• IMSXpress

  http://www.imsxp.com/00Home/IsoXpHome.aspx
  Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available.

• Inflexxion, Inc.

  http://www.inflexxion.com/health-research/overview
  Turnkey solution for risk management needs that integrates sensitive surveillance with sophisticated signal detection, signal verification, and targeted prevention and intervention programs.

• Infonetica

  http://www.gcptraining.org.uk/
  GCP online training course provides a comprehensive guide to the basic principles, regulations, and guidelines of ICH good clinical practice.

• Innovative Consultancy Services

  http://www.pharmaceutical-consultancy.com/
  Indian pharmaceutical consultant company providing services in regulatory affairs, pharmaceutical dossiers, product/process development, and validation services.

• International Regulatory Business Consultants, L.L.C.

  http://irb-c.com/
  Providing scientific and regulatory consultant services to the global pharmaceutical, nutritional supplement, medical device, and diagnostic product industries

• Japan MDC

  http://www.j-mdc.com/
  Regulatory consulting firm for international medical device companies interested in expanding their market penetration in Japan.

• Jim Colyn & Associates Quality Consultants, LLC

  http://www.jcolynconsulting.com/
  Consulting services targeting compliance and performance for human tissue processors, tissue recovery organizations, organ procurement organizations, eye banks, reproductive banks, and medical device manufacturers.

• Jouhou Koukai Services LLC

  http://www.jouhoukoukai.com/
  Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market.

• Kamm & Associates

  http://www.fda-consultant.com/
  Specializes in assisting businesses with compliance of GMP/QSR regulations.

• Kemic Bioresearch

  http://www.kemic.com/
  Kemic Bioresearch provides consulting, research and training in the pharmaceutical sciences (pharmacokinetics, pharmacology and toxicology).

• Kennedy Writing Service (KWS)

  http://www.kennedywritingservice.com/
  Medical writing and proofreading company.

• Kobridge Consulting Ltd

  http://www.kobridgeconsulting.com/
  Quality and regulatory services to register medical devices in different markets. Supplier audits in Asia. Based in Korea.

• Lachman Consultants

  http://www.lachmanconsultants.com/
  Offers consultancy services to prevent and resolve compliance problems and to develop strategies for the submission and approval of drugs, biologics, and devices.

• Lewis CMC Consulting

  http://www.lewiscmc.com/
  Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services.

• Lionpharm Regulatory Consulting GmbH

  http://www.lionpharm.com/
  Lionpharm is an independent consultancy company providing all kind of regulatory affairs services covering the whole life-cycle of medicinal products in Europe.

• Lorenz LIfe Sciences

  http://www.lorenz.cc/
  Regulatory affairs eCTD software and service for electronic submission management for companies with USA FDA, Canada, Europe, EMEA, Japan PMDA agencies.

• Mandell Horwitz Consultants LLC

  http://mandellhorwitzconsulting.com/
  Regulatory and scientific consulting for medical devices and other FDA-regulated products.

• MarcM Consulting Canada

  http://www.marcmconsulting.ca/
  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 services offered in English, Portuguese, and Spanish.

• Masy BioServices

  http://www.masy.com/
  Helps life science companies analyze and improve the quality of their research laboratories and production environments, playing a focused role in the development and delivery of leading drugs and devices used to improve patients' lives.

• MDI Consultants. Inc.

  http://www.mdiconsultants.com/
  A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries.

• Med Device Advisors

  http://www.meddeviceadvisors.com/
  Offer FDA compliant medical device standard operating procedures (SOP) for sale. Customization service is also available.

• Medcon Taiwan, Inc.

  http://www.medcon-taiwan.com/
  A Taiwan-based regulatory affairs consultant to the medical and life science industry

• MEDIcept

  http://www.medicept.com/
  MEDIcept is a vertically integrated consulting firm specializing in contract engineering, quality assurance, and regulatory consulting.

• Medius AG

  http://www.medius-ag.ch/
  Consulting and service company based in Switzerland, engaged in regulatory affairs of pharmaceuticals, medical devices, and in vitro diagnostics.

• MundoMed

  http://www.mundomed.nl/
  MundoMed is a consultancy based in Holland which specializes in CE-marking medical devices in Europe.

• MWA Consulting, Inc.

  http://www.gxpsrus.com/
  Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs.

• NDA

  http://www.ndareg.com/
  NDA is a European regulatory affairs and patient safety consultancy.

• NJK & Associates, Inc.

  http://njkconsulting.com/
  A collaborative group of industry consultants serving the medical device and IVD industry.

• Obelis Group

  http://obelis.net/
  Offers CE marking, US agent services to non-European medical devices manufacturers under AIMD, MDD, and IVD, under EU directives from Brussels, Belgium.

• OMSBAR

  http://www.omsbar.com/
  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 medical device personnel.

• Online GCP Training

  http://www.onlinegcp.com/
  Online good clinical practice training.

• Oracle Consulting Group

  http://www.fdamaze.com/
  Consultants for FDA and internationally regulated medical device firms, specializing in submissions, compliance, warning letter responses, inspection responses, quality system compliance, auditing and training

• Pennington Pharmaceutical Services LLC

  http://www.ppspharmrx.com/
  Regulatory compliance solutions targeted for small-to-medium sized pharmaceutical companies.

• Perseus Partners

  http://www.perseus.be/
  Consulting group headquartered in Belgium. They manage biosafety and biotechnology compliance requirements.

• PH PharmAnalysis GmbH

  http://www.pharmanalysis.de/
  Consultancy based in Germany that offers scientific and regulatory services for the pharmaceutical industry.

• Pharma-EU s.r.o.

  http://www.pharma-eu.com/
  Provides consulting services to pharmaceutical regulatory affairs professionals in the European Union.

• Pharmaceutical Development Group

  http://www.pharmdevgroup.com/
  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 cGMP inspections.

• Pharmaceutical Regulatory Services, Inc.

  http://www.pharmregservices.com/
  Provide clinical and regulatory support of all phases of global drug development with operations in over 80 countries on all continents.

• Pharmalink Consulting

  http://www.pharmalinkconsulting.co.uk/
  For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC

• PharmaReady

  http://www.pharmaready.com/
  A fully integrated web-based eDMS and eCTD Submissions Solution Suite.

• PharmAssure

  http://www.pharmassure.com.au/
  Australian pharmaceutical consulting services for validation and FDA and TGA GMP/GLP compliance.

• PinneyAssociates

  http://www.pinneyassociates.com/
  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.

• Prisym ID Life Sciences

  http://www.prisymid.com/
  Validated labeling systems and inventory management software systems designed specifically for FDA 21 CFR Part 11 regulated environments.

• PRS Clinical Ltd

  http://www.prs-clinical.com/
  Provider of clinical trial services

• Q-NET LLC

  http://www.ce-authorizedrepresentative.eu/
  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.

• Qarad

  http://www.qarad.com/
  Specializing in CE marking, services for medical devices and also for manufacturers of personal protective equipment, in vitro diagnostics and medical test laboratories.

• QMR, LLC

  http://www.qmr-llc.com/
  Medical device, pharmaceutical, diagnostic, and other life science quality assurance and regulatory affairs consulting services.

• Qserve Group

  http://www.qservegroup.com/
  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.

• QSite

  http://www.qsitemed.com/
  Consulting group focused on the medical device industry. Services include advice on international regulatory affairs, clinical affairs, biostatistics, and global quality assurance.

• Quadras

  http://www.quadras.de/
  Service partner for international approval, registration, listing, and certification of medical devices in Europe, Asia, America, and Australia.

• QualiMedd

  http://www.qualimedd.com/
  An independent UK management consultancy working within the areas of product development specializing in medical devices and in-vitro diagnostics.

• Quality First International Ltd.

  http://www.qualityfirstint.com/
  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

• Quality Implementation Services Inc.

  http://www.qisfdaconsultants.com/
  Provides consulting services to pharmaceutical, medical device, and life sciences industries in quality assurance, quality control, and regulatory affairs compliance.

• Quality Medical Regulations Services

  http://www.qmrs.com/
  Provides quality assurance documentation support. Assists in site licensing, product registration, HACCP development and implementation. Ottawa, Canada.

• Quality Vectors

  http://www.quality-vectors.com/
  Provide validations, cGxP compliance, systems engineering, and quality systems to pharmaceutical, medical device, and biotechnology industries.

• Qware Riskmanager

  http://www.risk-online.com/
  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.

• R. A. Q .A. Associates

  http://www.raqaassociates.com/
  Provides FDA and ISO related consulting services to medical device and pharmaceutical companies. Specialize in helping firms with regulatory and cGMP problems, constructing and implementing entirely new quality and regulatory systems or improving existing systems.

• reg-info.com

  http://reg-info.com/
  A collection of links to websites with information relating to regulatory affairs, regulatory intelligence, and the regulation of medicines.

• RegIntel Ltd.

  http://www.regintel.com/
  Provides international regulatory solutions to the pharmaceutical and biologics industries.

• Regulatory Affairs Associates LLC

  http://www.regaffairs.net/
  RAA (regulatory affairs consultancy)

• Sagaem For Life

  http://www.sagaem.it/
  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.

• Salamandra LLC

  http://www.salamandra.net/
  Provides strategic, technical, and regulatory consulting services to the pharmaceutical industry for drug, biologic, and device development.

• Samarind Ltd

  https://samarindrms.com/
  Offers a software package for the pharmaceutical industry that manages regulatory affairs and licence submissions.

• Seagull Comm.V

  http://seagull.eu/
  Belgian company that provides consulting services in the fields of regulatory affairs, quality assurance, pricing and reimbursement, pharmacovigilance, and medical writing for medicinal products.

• SeerPharma

  http://seerpharma.com/
  Specializing in the delivery of technical compliance and validation, QA knowledge, and GMP training solutions to the pharmaceutical, medical device and biotechnology industries.

• Shafi Consultancy

  http://www.shaficonsultancy.com/
  Firm specializing in providing SAS training and expertise in working with clinical trials.

• Sigma Biomedical

  http://www.sigmabiomedical.com/
  Supports biomedical research and medical device development by providing custom solutions.

• Sindor Healthcare Consulting

  http://www.sindor.com/
  Based in Singapore, providing healthcare consulting including regulatory affairs, quality management systems, marketing, and business development.

• SMB Validation and Compliance Group

  http://www.smbvalidation.com/
  Works to get your equipment into production promptly while ensuring that all regulatory requirements are systematically fulfilled with a minimum of interference with operations.

• Smith and Associates

  http://www.fdaconsultants.com/
  A consulting firm specializing in regulatory affairs for medical device manufacturing.

• Strategic Compliance International, Inc.

  http://www.sci-nc.com/
  Specializes in regulatory compliance consulting for biologics, medical devices and drug companies.

• Supremus Group

  http://www.training-hipaa.net/
  Provides HIPAA training courses in multiple formats both onsite and online.

• Tarius A/S

  http://www.tarius.com/
  Provides the pharmaceutical, biologics and medical device industries with regulatory and compliance information. Includes services provided, company news and events.

• TDC Software

  http://www.tdc.fr/en/products/tdc_fmea.php
  Engineering software suite covering risk management.

• Tecno-med Ingenieros

  http://www.tecno-med.es/
  Located in Barcelona, Spain - helps manufacturers to obtain CE mark for their medical devices.

• The Gnomon Group, LLC

  http://thegnomongroup.com/
  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.

• The Horizon Phoenix Group LLC

  http://www.horizonphoenix.biz/
  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.

• The Matthews Consultancy

  http://www.tmconsultancy.com/
  European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development.

• Thermal Compliance Ltd

  http://www.thermalcompliance.co.uk/
  Thermal mapping and autoclave validation

• THINQ Compliance Ltd.

  http://www.thinqcompliance.com/
  The integration of services and software to provide competitive compliance, quality advocacy and thought leadership.

• Thomas E. Colonna Ph.D./J.D. & Associates

  http://www.tcolonna.com/
  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.

• TopPharm Consulting

  http://www.regulatory-affairs.pl/
  Regulatory affairs consultancy in Poland and EU (MRP, DCP, national, medical devices, food supplements, and scientific dossier consultation).

• TRAC Services

  http://www.tracservices.co.uk/
  A UK based company providing regulatory affairs consultancy and patient information leaflet user testing to the pharmaceutical industry.

• Tumont Limited

  http://www.tumont.co.uk/
  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.

• Universal Regulatory Inc.

  http://www.universalregulatory.com/
  Specializing in regulatory strategy development, preparation, and review of regulatory submissions.

• Validation in Partnership Ltd

  http://www.vipltd.co.uk/
  Specializing in the provision of validation and CGMP (Current Good Manufacturing Practice) compliance services.

• Validation Online Net

  http://www.validation-online.net/
  Generic downloadable documents that are cGMP compliant.

• Validation Professionals, Inc

  http://www.validationprofessionals.com/
  Offers a full range of validation, compliance and technical services for the pharmaceutical, biotechnology and medical device industries.

• Validation Systems, Inc.

  http://www.validationsystems.com/
  They 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.

• Validation Technologies, Inc.

  http://www.validation.org/
  Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries.

• Veirup Consult

  http://www.veirupconsult.dk/
  Danish regulatory affairs consultancy

• VTS Consultants, Inc.

  http://www.vtsconsultants.com/
  Validation and regulatory consulting services for the pharmaceutical, biotechnology, and medical device industries.

• Wainwright Associates

  http://wainwrightassociates.co.uk/
  UK based regulatory affairs consultants offering a wide range of services to international companies in the pharmaceutical, medical device, nutritional and healthcare industry.

• WMDE

  http://www.wmde.nl/
  Medical device regulatory affairs

• Wolter Kluwers MediRegs

  http://www.wolterskluwerlb.com/health/
  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.

• xFDA Inc.

  http://www.xfda.com/
  Provides services to small and mid-sized pharmaceutical and device companies including biotechnology in the areas of preclinical, clinical, CMC and regulatory.

• Zodiac Pharmaceutical Services

  http://www.zodiacpharma.com/
  Provides consulting services in the areas of patent, regulatory affairs, marketing research, and QA/GMP documentation for small to medium size pharmaceutical companies.

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