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Home / Business / Business Services / Consulting / Medical and Life Sciences / Regulatory Affairs
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Web Sites
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- Bio-Reg Associates, Inc. - Regulatory consulting firm assisting medical device, biologic, pharmaceutical, and biotech manufacturers meet US and international regulatory requirements.
www.bioreg.com
- Coda Corp. USA - Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide.
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.
codingcompliance.com
- Compliant Projects Ltd - Pharmaceutical Validation, GxP Audit & Project Management Services - Compliant Projects Ltd is an Independent Provider of FDA Compliance, Validation, GxP, Quality & Project Management Services to the Pharmaceutical Industry.
www.compliantprojects.co.uk
- Comprehensive Solution Affiliates - HIPAA consulting and solution packages.
www.csa-hipaa.com
- Drumbeat Dimensions Inc. - Professional compliance management company dedicated to developing products and tools for assessing, enhancing, and maintaining regulatory compliance.
www.drumkey.com
- Ehrreich Consulting, Inc. - Regulatory consultants expediting FDA approval by solving tough scientific, clinical, & regulatory issues which may arise pre- and post-submission.
www.regsolutions.com
- Entrinsik -- Managing Human Capital and Employee Development - Entrinsik's 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.
www.entrinsik.com
- FDA Regulatory Affairs Consultant - Dr. Colonna 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
www.tcolonna.com
- HIPAA and OIG Compliance Plan for Doctors - Health care providers compliance plan for doctors for HIPAA and OIG compliance regulations and chart audits.
www.complianceplanfordoctors.com
- ISOComp, Inc. - ISOtrain software distributors and consultants to bring training processes into FDA compliance and provide general consulting for pharmaceutical and biotechnology companies.
www.isocomp.com/home.asp
- Kamm & Associates - 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.
www.fda-consultant.com
- Lachman Consultant Services - 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
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.
www.drflynnconsulting.com
- Liquent, Inc. - Established provider of regulatory report publishing and submission consulting services and software for the global life sciences community.
www.liquent.com
- MDI Consultants, Inc. - FDA, IVDD, CE mark, HACCP, ISO9000, and GMP compliance consulting company for the medical device industry.
www.fdaconsulting.net
- Medical Devices Consulting - Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services.
www.qsrhelp.com
- Medical Equipment Compliance Associates (MECA) Consulting - MECA Consulting offers medical equipment safety standard compliance assistance for UL and other third party safety marks, CE marking under the MDD, and assistance with FDA 510(k) submissions.
www.mecaconsulting.net
- MedPharmTec Services - German consultant for the pharmaceutical industry.
www.medpharmtec.de
- Milestone Biomedical Associates - A contract consulting services organization specializing in the nonclinical product development of drugs, biologics, and medical devices.
www.criver.com/milestone
- Newland GxP Consultancy - European pharmaceutical GxP Consultancy.
www.newland-gxp.co.uk
- Pirovano Management - European medical device regulatory consultant
www.dariopirovano.com
- 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.
www.reg123.com
- Regulatory Affairs Consulting - Regulatory affairs consulting services to the pharmaceutical and related industries.
www.newdrugapprovals.com
- Regulatory Affairs, North America LLC - Regulatory affairs consultancy headquartered in North Carolina.
www.ranallc.com
- Regulatory and Validation Provider - 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
www.validationassociates.com
- Smith and Associates - A consulting firm specializing in regulatory affairs for medical manufacturing.
www.fdaconsultants.com
- The Due Diligence Group a Life Sciences Due Diligence company - Specialized due diligence services for venture capital and licensing opportunities in the life sciences industry.
www.theduediligencegroup.com
- The Horizon Phoenix Group Quality System Consultants - Consulting company providing assistance to companies developing ISO9001 and CE systems. Its clients range from a small niche market manufacturer to the United Nations.
www.horizonphoenix.com
- The Matthews Consultancy - European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development.
tmconsultancy.com
- Validation Masters, Inc. - Company serving the pharmaceutical manufacturing and clinical research industries.
www.validationmasters.com
- Westerwald-Institute for Biological, Pharmaceutical and Pharmacological Research - 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.
members.aol.com/wwinstitut
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