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Sites:

  •  Drumbeat Dimensions Inc.  - http://www.drumkey.com
     Professional compliance management company dedicated to developing products and tools for assessing, enhancing, and maintaining regulatory compliance.
  •  Bio-Reg Associates, Inc.  - http://www.bioreg.com
     Regulatory consulting firm assisting medical device, biologic, pharmaceutical, and biotech manufacturers meet US and international regulatory requirements.
  •  Medical Devices Consulting  - http://www.qsrhelp.com
     Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services.
  •  Validation Masters, Inc.  - http://www.validationmasters.com/
     Company serving the pharmaceutical manufacturing and clinical research industries.
  •  Ehrreich Consulting, Inc.  - http://www.regsolutions.com
     Regulatory consultants expediting FDA approval by solving tough scientific, clinical, & regulatory issues which may arise pre- and post-submission.
  •  Coda Corp. USA  - http://www.CodaCorpUSA.com
     Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide.
  •  Liquent, Inc.  - http://www.liquent.com
     Established provider of regulatory report publishing and submission consulting services and software for the global life sciences community.
  •  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.
  •  Kamm & Associates  - http://www.fda-consultant.com
     Daniel Kamm, P.E., C.Q.A., is the Principal Engineer of Kamm & Associates. He is an electronics engineer and regulatory affairs executive with over thirty years experience in the medical device business, specializes in Good Manufacturing Practices auditing, consulting, and training.
  •  Lachman Consultant Services  - http://www.lachmanconsultants.com
     Provides expert technical consultation in the areas of FDA Related Activities, Quality Control / Quality Assurance, Validation / Qualification, Stability / Expiration Dating, Research and Development of Pharmaceutical Dosage Forms, New Facilities Construction for R&D and Production to the Pharmaceutical, Biotechnology, Device, Diagnostic and Allied Health Industries
  •  Leonard T. Flynn  - http://www.drflynnconsulting.com
     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.
  •  Compliant Projects Ltd.  - http://www.compliantprojects.co.uk/
     Independent provider of FDA compliance, validation, GxP, quality and project management services to the pharmaceutical industry.
  •  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.
  •  Entrinsik  - http://www.entrinsik.com
     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.
  •  Westerwald-Institute  - http://members.aol.com/wwinstitut
     German consulting group experienced in different licensing procedures of drugs and medicinal products at the national and European level. Website is available in both German and English.
  •  Reg123.com  - http://www.reg123.com
     Reg123.com is a portal for the new medicinal product development community with a focus on regulatory affairs and the pharmaceutical drug development process.
  •  The Matthews Consultancy  - http://tmconsultancy.com
     European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development.
  •  Regulatory and Validation Provider  - http://www.validationassociates.com
     Validation Associates, Inc. (VAI) provides regulatory compliance consulting services including 21 CFR Part 11 gap assessments, software and computer system validation, process validation, and system and vendors audits to life sciences companies through its network of consultants and industry experts
  •  The Arazy Group  - http://www.arazygroup.com
     Medical Device RA and Quality System Consultants
  •  KAI  - http://www.keiperassoc.com
     Regulatory and validation service provider.
  •  Validation and cGMP Compliance  - http://www.cqionline.com/
     Equipment and Software Validation. Part 11 of 21 CFR Compliance. Regulations, cGMP, Validation knowledge base. FDA Warning letters.
  •  Online HIPAA training  - http://www.bytesizelearning.com/hipaa.htm
     Online training for HIPAA compliance for insurance professionals.
  •  Pensa Technology Solutions Inc.  - http://www.gmps.com/
     21 cfr part 11 regulatory compliance of FDA pharmaceutical GMP validation for ERP life sciences computer information systems.
  •  RegIntel Ltd.  - http://www.regintel.com
     Provides international regulatory solutions to the pharmaceutical and biologics industries.
  •  Lewis CMC Consulting  - http://www.lewiscmc.com
     Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services.
  •  QRC Associates  - http://www.qrcassociates.com
     QRC Associates provides management with cGMP and QSR advice.
  •  Perkins and Perkins  - http://www.perkinsandperkins.net
     FDA consultants Perkins and Perkins, Inc. conduct mock FDA audits to insure Good Clinical Practice (GCP) compliance, quality assurance and FDA audit preparation.
  •  QCT Solutions, LLC  - http://www.qctsolutions.com
     Specialities include cGMP systems, for cause audits, and PAI preparation.
  •  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.
  •  ISOComp, Inc.  - http://www.isocomp.com/
     ISOtrain software distributors and consultants to bring training processes into FDA compliance and provide general consulting for pharmaceutical and biotechnology companies.
  •  GMP Online Consultancy  - http://www.gmp-online-consultancy.com
     European-based, Good Manufacturing Practice (GMP) Online Consultancy
  •  Medical Device Consultants, Inc. (MDCI)  - http://www.mdci.com
     provides worldwide regulatory, clinical, and quality assurance consulting services to medical device and diagnostic product manufacturers to meet US, Canadian, and European requirements.
  •  21 CFR Consulting  - http://www.21cfrconsulting.com/
     Privately held virtual company in Encinitas, California, offering quality and risk assesments, remediation, IT system validation and training for FDA regulated industries.
  •  Biotech Consultant LLC  - http://www.biotech-consultant.com
     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, pharmacogenomics, analyte specific reagent (ASR) regulatory compliance, and proteomics), medical device software (including bioinformatics), CPT coding reimbursement, and biotechnology-based products.
  •  SDCS  - http://devicecompliance.com/
     Consultant and advocate for the medical device industry on issues of regulatory and standards compliance, risk management (ISO 14971) and general device safety.
  •  Doctor Device Consultant  - 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.
  •  Marion Weinreb and Associates, Inc.  - http://gmpsrus.com
     Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs.
  •  Validation Technologies, Inc.  - http://www.validation.org/
     Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries.
  •  Harpaz Consulting Services  - http://www.harpazconsulting.com/
     Providing GMP compliance consultation, regulatory and technical expertise to manufacturers of drug products, active pharmaceutical ingredients, and medical devices worldwide.
  •  GMG BioBusiness  - http://www.gmgbio.com/
     UK based product development service company providing strategic support and regulatory affairs resources.
  •  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
  •  GMP Experts  - http://www.gmpexperts.com/
     Offer analysis, development, documentation, validation, support and assistance to industries regulated by FDA and similar international agencies.
  •  Tarius Interactive  - http://www.tarius.com
     Tarius Interactive is a world-leading pharmaceutical regulatory intelligence and knowledge management system based on XML architecture.
  •  QuadraMed  - http://www.quadramed.org.uk/
     A pharmaceutical regulatory company with european affiliated offices specializing in marketing authorizations, european clinical trials, mutual recognition procedures, and orphan drug designations.
  •  FDACompliance.Net  - http://FDACompliance.Net
     Provides Members with searchable databases as well as full text searching of regulatory compliance topics.
  •  Medical device consultants  - 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
  •  IDEC Validation Ltd  - http://www.idecvalidation.com/
     Provider of Quality & Compliance services to the Pharmaceutical / Biotechnology sector. Primarily assist organisations in the CSV field satisfy Regulatory and Compliance requirements. IVL has extensive field knowledge in the implementation of compliance solutions.
  •  AQA  - http://www.aqapress.com
     Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available.
  •  Computer Validation Services & 21 CFR Part 11  - http://www.osrsolutions.com/osr_solutions.html
     OSR Solutions strongly believes that Computer Validation and Part 11 Compliance should not be a series of point solutions only addressing regulatory risk but is a significant opportunity for business transformation to streamline Operations through enabling technology"
  •  Octagon Research  - http://www.octagonresearch.com
     Using an electronic submission system (eSub), Octagon assists clients in the achievement an approved regulatory submission.
  •  SMB Validation and Compliance Services Group  - http://www.smbvalidation.com/
     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.
  •  MDI Consultants  - http://www.mdiconsultants.com
     A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries.
  •  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.
  •  FDALive.com  - http://www.FDALive.com
     Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CD's, videotapes and transcripts available.
  •  Aitheras, LLC.  - http://www.aitheras.com/
     Offers validation, ERP/CRM, testing, and enterprise effeciency services for medium and large scale organizations from Rockville, Maryland.
  •  Seraphim Life Sciences Consulting LLC  - http://www.SeraphimLifeSciences.com
     Seraphim provides integrated consulting and due diligence on regulatory and operations issues for life sciences companies and investors.
  •  BesTech regulatory consulting  - http://www.bestechconsulting.biz
     BesTech consulting services guides medical companies through the FDA and CE compliance processes to ensure their business success. We provide solutions for regulatory compliance, product safety, litigation support and design & development of medical devices.
  •  UK Medical Device Consultancy  - http://www.medicaldeviceconsultancy.co.uk
     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 partner search.
  •  Jouhou Koukai Services  - http://www.jouhoukoukai.com
     Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market.
  •  Global Regulatory  - http://www.GlobalRegulatory.com
     Pharmaceutical, medical device, biotechnology, food, and nutraceutical consulting for the international markets.
  •  ERA Consulting Group  - http://www.eraconsulting.com
     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.
  •  BuzzeoPDMA, Inc.  - http://www.buzzeopdma.com
     PDMA Compliance Auditing Service, Reconciliation Services, Field Inventory & System Auditing Services and Validation, State Requirements & Licensing, DEA Regulatory & Operational Solutions, Training, Security Vulnerability Assessment (SVA)
  •  Aquasol Solutions. Inc.  - http://aquasol-solutions.com
     Aquasol Solutions, Inc. is a professional Drug Regulatory Affairs consulting firm, providing regulatory solutions to drug manufacturing and registration problems.
  •  Applied Regulatory Consulting  - http://www.appliedregulatory.com
     Applied Regulatory Consulting Limited provides regulatory consultancy to the pharmaceutical industry, including strategic regulatory consultancy, project management, training, regulatory agency interactions and regulatory submissions.
  •  European Authorized Representative  - http://www.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.
  •  Process compliance and validation  - http://www.pcv.ltd.uk
     PCV provides Validation Master Plans, User Requirement and Technical Specification, Vendor audit, FAT, protocols IQ - OQ - PQ and reports.
  •  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.
  •  ASG Inc.  - http://www.asg-inc.com
     Clinical Consulting: Specializing in regulatory affairs, sas programming, biotechnology careers, data management companies, staffing pharmaceutical, consulting, statistics, biotechnology, sas, and cro.
  •  Pharmalink Consulting  - http://www.pharmalinkconsulting.co.uk
     For all European regulatory affairs issues - CTA/IMPD submissions, regulatory compliance issues, and CMC
  •  Kinesis Pharma BV  - http://www.kinesis-pharma.com/index2.htm
     Consultants in drug development. Located in the Netherlands.
  •  Validation Solutions Ltd  - http://www.validation-solutions.com
     Validation and compliance services for the Pharmaceutical Industry. Specialists in computer systems validation and electronic records and signatures.
  •  The Tamarack Group  - http://www.thetamarackgroup.net
     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).
  •  OMSBAR  - http://www.omsbar.com/
     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 medical device personnel.
  •  PharmaCon GmbH  - http://www.pharma-con.ch/index2.html
     Consulting in regulatory strategy for medicinal products.
  •  RegulatoryPro.com  - http://www.regulatorypro.com
     RegulatoryPro offers regulatory affairs consulting services to the biopharmaceutical, medical device and other FDA-regulated industries.
  •  Spherelink FDA Consulting  - http://spherelink.com
     Spherelink provides FDA consulting and international trade consulting between Asia and the United States.
  •  Creative Consultants India  - http://www.creativeconsultantsindia.com
     India-based agency engaged in preparation of registration dossiers for export of drug formulations. We also prepare clinical trial reports, training manuals, drug master files, SOPs, and validation reports.
  •  Medcon Taiwan, Inc.  - http://www.medcon-taiwan.com
     A Taiwan-based regulatory affairs consultant to the medical and life science industry
  •  Delphi Consulting  - http://www.delphiconsulting.com
     Delphi Consulting Group provides US FDA consulting services for medical devices.
  •  Alphapharma Consulting  - http://www.alphapharma.com/aboutus.html
     Good Manufacturing Practice (GMP) consulting services to the pharmaceutical industry.
  •  WellKang LLC  - http://www.510k.us/510k-submission-procedure.html
     Regulatory affairs consultancy specializing in medical devices.
  •  HDM Corp.  - http://www.hdmcorp.com
     Offers Internet-based HIPAA privacy and confidentiality training software for payers, providers and academia as well as HIPAA-compliant medical billing software for providers.
  •  Horizon Phoenix Group-Medical Quality Consulting Firm  - 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.
  •  FDC Services  - http://fdcservices.com
     A regulatory affairs and quality systems consulting company serving the medical device and pharmaceutical industries.
  •  CMAC Consultancy  - http://www.cmacusa.com
     Provides services like documentation and change control, validation and qualification execution, calibration and preventive maintenance, GXP training & implementation, project administration and commissioning, as well as, IT services/operation management.
  •  Perseus Partners  - http://www.perseus.be
     Consulting group headquartered in Belgium. They manage biosafety and biotechnology compliance requirements.
  •  Masy Systems  - http://www.masy.com/
     Validation and calibration services for the pharmaceutical, biotech, and related fields. Information on equipment and shipper studies.
  •  Consultifarma  - http://www.consultifarma.com
     Consultoria especializada no registro de produtos e empresas sujeitas a vigilancia sanitaria, assim como em atividades que abrangem: pesquisa clinica, controle de qualidade e estabilidade, treinamento, marketing farmaceutico etc.
  •  Innovative Consultancy Services  - http://www.pharmaceutical-consultancy.com
     We are an Indian pharmaceutical consultant company established in the year 1998 and providing services in regulatory affairs, pharmaceutical dossiers, product/process development, and validation services.
  •  FDA Compliance Solutions  - http://www.fdacompliancesolutions.com
     FDA Compliance Solutions' consultants provide a full range of FDA compliance services, including computer system validation, software validation, process validation, pharmaceutical validation and consulting.
  •  Smith and Associates  - http://www.fdaconsultants.com/
     A consulting firm specializing in regulatory affairs for medical device manufacturing.
  •  SeerPharma  - http://www.seerpharma.com.au
     SeerPharma is a professional consultancy specialising in the delivery of technical compliance and validation, QA knowledge and GMP training solutions to the pharmaceutical, medical device and biotechnology industries.
  •  Estrin Consulting Group, Inc.  - http://yourFDAconsultant.com
     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.
  •  Schell Associates  - http://schell-associates.com
     Consulting services including regulatory affairs, preclinical and GLP testing, manufacturing, quality, compliance, and clinical studies.
  •  Accurate FDA Consultants  - http://www.accuratefdaconsulting.com
     FDA compliance and regulatory consulting to help clients develop efficient and effective quality systems.
  •  Quality Solutions  - http://www.validationprofessionals.com
     Validation Professionals, Inc. (VPI) offers a full range of validation, compliance and technical services for the pharmaceutical, biotechnology and medical device industries.
  •  Di Renzo Regulatory Affairs  - http://www.pharmaflash.com
     Di Renzo Regulatory Affairs is a pharmaceutical consultant aiding companies that need to register products (from medicines/dietary supplements and medical devices to cosmetics) at the AIFA and the Italian Ministry of Health.
  •  THINQ Compliance Ltd.  - http://www.THINQcompliance.com
     The integration of services and software to provide competitive compliance, quality advocacy and thought leadership.