ABC HOME web search Web Search web search Web Directory web search Image Search web search Video Search web search Shopping web search 4WX Weather web search Domain Search
ABC Directory
Arts Business Computers Games Health Home Kids News
Recreation Reference Regional Science Shopping Society Sports Adult

Add your website to this category
ABC HOME: Top: Business: Business_Services: Consulting: Medical_and_Life_Sciences: Regulatory_Affairs:

Regulatory Affairs (125)

Also See:
Sponsors:
Web Sites In this Category:

Drumbeat Dimensions Inc. Open in a new browser window  
   Professional compliance management company dedicated to developing products and tools for assessing, enhancing, and maintaining regulatory compliance.
   http://www.drumkey.com
Bio-Reg Associates, Inc. Open in a new browser window  
   Regulatory consulting firm assisting medical device, biologic, pharmaceutical, and biotech manufacturers meet US and international regulatory requirements.
   http://www.bioreg.com
Medical Devices Consulting Open in a new browser window  
   Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services.
   http://www.qsrhelp.com
Regulatory Affairs Consulting Open in a new browser window  
   Regulatory affairs consulting services to the pharmaceutical and related industries.
   http://www.newdrugapprovals.com
Validation Masters, Inc. Open in a new browser window  
   Company serving the pharmaceutical manufacturing and clinical research industries.
   http://www.validationmasters.com/
Ehrreich Consulting, Inc. Open in a new browser window  
   Regulatory consultants expediting FDA approval by solving tough scientific, clinical, & regulatory issues which may arise pre- and post-submission.
   http://www.regsolutions.com
Coda Corp. USA Open in a new browser window  
   Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide.
   http://www.CodaCorpUSA.com
Liquent, Inc. Open in a new browser window  
   Established provider of regulatory report publishing and submission consulting services and software for the global life sciences community.
   http://www.liquent.com
Thomas E. Colonna Ph.D./J.D. & Associates Open in a new browser window  
   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
Kamm & Associates Open in a new browser window  
   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 aud
   http://www.fda-consultant.com
Lachman Consultant Services Open in a new browser window  
   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 Construc
   http://www.lachmanconsultants.com
Leonard T. Flynn Open in a new browser window  
   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
Compliant Projects Ltd. Open in a new browser window  
   Independent provider of FDA compliance, validation, GxP, quality and project management services to the pharmaceutical industry.
   http://www.compliantprojects.co.uk/
MedPharmTec Services Open in a new browser window  
   German consultant for the pharmaceutical industry.
   http://www.medpharmtec.de
Coding Compliance Solutions Open in a new browser window  
   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
Entrinsik Open in a new browser window  
   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
Westerwald-Institute Open in a new browser window  
   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.
   http://members.aol.com/wwinstitut
Pirovano Management Open in a new browser window  
   European medical device regulatory consultant
   http://www.dariopirovano.com
Reg123.com Open in a new browser window  
   Reg123.com is a portal for the new medicinal product development community with a focus on regulatory affairs and the pharmaceutical drug development process.
   http://www.reg123.com
The Matthews Consultancy Open in a new browser window  
   European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development.
   http://tmconsultancy.com
Newland GxP Consultancy Open in a new browser window  
   European pharmaceutical GxP Consultancy.
   http://www.newland-gxp.co.uk
Regulatory Affairs, North America LLC Open in a new browser window  
   Regulatory affairs consultancy headquartered in North Carolina.
   http://www.ranallc.com
Milestone Biomedical Associates Open in a new browser window  
   A contract consulting services organization specializing in the nonclinical product development of drugs, biologics, and medical devices.
   http://www.criver.com/milestone/
Regulatory and Validation Provider Open in a new browser window  
   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 it
   http://www.validationassociates.com
21 CFR Part 11 Compliance Resource Open in a new browser window  
   A resource for issues surrounding the FDA's 21 CFR Part 11 Rule on electronic records and signatures.
   http://www.21cfrpart11.com
The Arazy Group Open in a new browser window  
   Medical Device RA and Quality System Consultants
   http://www.arazygroup.com
KAI Open in a new browser window  
   Regulatory and validation service provider.
   http://www.keiperassoc.com
Hippa Custom Open in a new browser window  
   HIPAA compliance, training, and assessment.
   http://www.hipaacomplianceregulationtraining.com
New World Regulatory Solutions/SOOP International Open in a new browser window  
   Regulatory, quality and technical affairs guidance for international medical diagnostic device manufacturers.
   http://soop.us
ATC Corp. - American Technical Consultants Open in a new browser window  
   Consultant Group specializing in providing services on FDA Compliance Issues to the Food, Drug and Cosmetic industry.
   http://www.atccorp.net/
Validation and cGMP Compliance Open in a new browser window  
   Equipment and Software Validation. Part 11 of 21 CFR Compliance. Regulations, cGMP, Validation knowledge base. FDA Warning letters.
   http://www.cqionline.com/
Online HIPAA training Open in a new browser window  
   Online training for HIPAA compliance for insurance professionals.
   http://www.bytesizelearning.com/hipaa.htm
Pensa Technology Solutions Inc. Open in a new browser window  
   21 cfr part 11 regulatory compliance of FDA pharmaceutical GMP validation for ERP life sciences computer information systems.
   http://www.gmps.com/
Northvail Consulting - specializing in HIPAA compliance Open in a new browser window  
   Northvail Consulting provides HIPAA privacy and security compliance services to healthcare providers in Colorado and the surrounding region.
   http://www.northvail.com
International GCP Auditor Open in a new browser window  
   GCP and systems Auditor, Pharma Companies and CRO clients, numerous, since 1992. Clinical trial study site, sponsor and CRO audits, phase II to IV
   http://homepage.ntlworld.com/the.auditor
21 CFR Part 11: Worldwide Pharma Solutions Inc. "Compliance Specialists" Open in a new browser window  
   WWPSI provides 21 CFR Part 11 and chromatography validation services to pharmaceutical laboratories throughout USA, Puerto Rico, and the EU. Specialists ensure compliance for computer systems validation and laboratory systems automation.
   http://www.wwpsi.com
RegIntel Ltd. Open in a new browser window  
   Provides international regulatory solutions to the pharmaceutical and biologics industries.
   http://www.regintel.com
Lewis CMC Consulting Open in a new browser window  
   Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services.
   http://www.lewiscmc.com
QRC Associates Open in a new browser window  
   QRC Associates provides management with cGMP and QSR advice.
   http://www.qrcassociates.com
Perkins and Perkins Open in a new browser window  
   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
Lubin Consulting Inc. Open in a new browser window  
   Integrates cost-effective customized solutions, workflows, design controls and product development processes into medical device designs.
   http://www.lubinconsulting.com
QCT Solutions, LLC Open in a new browser window  
   Specialities include cGMP systems, for cause audits, and PAI preparation.
   http://www.qctsolutions.com
Chestnut Solutions Inc. Open in a new browser window  
   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/
Smith and Associates Open in a new browser window  
   A consulting firm specializing in regulatory affairs for medical device manufacturing.
   http://www.fdaconsultants.com/
ISOComp, Inc. Open in a new browser window  
   ISOtrain software distributors and consultants to bring training processes into FDA compliance and provide general consulting for pharmaceutical and biotechnology companies.
   http://www.isocomp.com/
The Due Diligence Group Open in a new browser window  
   Specialized due diligence services for venture capital and licensing opportunities in the life sciences industry.
   http://pages.ivillage.com/germainegross/
GMP Online Consultancy Open in a new browser window  
   European-based, Good Manufacturing Practice (GMP) Online Consultancy
   http://www.gmp-online-consultancy.com
Medical Device Technology Consultants - Cambridge UK Open in a new browser window  
   MDTc is an independent consultancy to the medical devices industry. Based near Cambridge, England, MDTc helps bring products to market and comply with regulatory requirements.
   http://www.mdtconsultants.co.uk/
Regulatory Affairs Associates LLC Open in a new browser window  
   RAA (regulatory affairs consultancy)
   http://www.regaffairs.net
Medical Device Consultants, Inc. (MDCI) Open in a new browser window  
   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
21 CFR Consulting Open in a new browser window  
   Privately held virtual company in Encinitas, California, offering quality and risk assesments, remediation, IT system validation and training for FDA regulated industries.
   http://www.21cfrconsulting.com/
ADN - IT Compliance Expertise for FDA regulated industries Open in a new browser window  
   Compliance for electronic record management for FDA regulated companies.
   http://www.adneurope.com
Biotech Consultant LLC Open in a new browser window  
   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
SDCS Open in a new browser window  
   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/
Doctor Device Consultant Open in a new browser window  
   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
Brandt Research Consulting LLC Open in a new browser window  
   Providing a wide range of consulting services in GCP, GLP and GMP compliance.
   http://www.brandtconsulting.us
Marion Weinreb and Associates, Inc. Open in a new browser window  
   Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs.
   http://gmpsrus.com
Validation Technologies, Inc. Open in a new browser window  
   Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries.
   http://www.validation.org/
Harpaz Consulting Services Open in a new browser window  
   Providing GMP compliance consultation, regulatory and technical expertise to manufacturers of drug products, active pharmaceutical ingredients, and medical devices worldwide.
   http://www.harpazconsulting.com/
GMG BioBusiness Open in a new browser window  
   UK based product development service company providing strategic support and regulatory affairs resources.
   http://www.gmgbio.com/
Quality First International Ltd. Open in a new browser window  
   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
GMP Experts Open in a new browser window  
   Offer analysis, development, documentation, validation, support and assistance to industries regulated by FDA and similar international agencies.
   http://www.gmpexperts.com/
Tarius Interactive Open in a new browser window  
   Tarius Interactive is a world-leading pharmaceutical regulatory intelligence and knowledge management system based on XML architecture.
   http://www.tarius.com
Medius AG - Drug Regulatory Affairs and Development Open in a new browser window  
   Medius is a consulting and service company based in Switzerland, engaged in regulatory affairs of pharmaceuticals, medical devices, and in vitro diagnostics.
   http://www.medius-ag.ch
QuadraMed Open in a new browser window  
   A pharmaceutical regulatory company with european affiliated offices specializing in marketing authorizations, european clinical trials, mutual recognition procedures, and orphan drug designations.
   http://www.quadramed.org.uk/
Compliance Associates - Life Science Software and Consulting Services Open in a new browser window  
   Compliance Associates is dedicated to providing the Life Science industry with solutions to complex regulatory and business critical requirements.
   http://www.complianceassociates.ca
FDACompliance.Net Open in a new browser window  
   Provides Members with searchable databases as well as full text searching of regulatory compliance topics.
   http://FDACompliance.Net
Medical device consultants Open in a new browser window  
   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
FDA Advisors with scientific and technical expertise Open in a new browser window  
   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
IDEC Validation Ltd Open in a new browser window  
   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 complian
   http://www.idecvalidation.com/
AQA Open in a new browser window  
   Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available.
   http://www.aqapress.com
Biologics Consulting Group- Regulatory Affairs Consultants for Manufacturers of biological products Open in a new browser window  
   Our staff of consultants has over 200 years total FDA regulatory experience and provide regulatory application support, "mock" FDA inspections, vendor and clinical trial site audits, statistical services, clinical trial design/review, and prepar
   http://www.biologicsconsulting.com
Computer Validation Services & 21 CFR Part 11 Open in a new browser window  
   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 enablin
   http://www.osrsolutions.com/osr_solutions.html
MedFO, Inc. - Medical Information Communication Consulting Open in a new browser window  
   Specialty consulting firm that focuses almost exclusively upon the strategy, operations, and functions of departments that fall under the Medical Affairs umbrella.
   http://www.medfoinc.com
Carexa Inc. Regulatory Consultants Open in a new browser window  
   Carexa's experienced consultants provide strategy and services for drug development and regulatory affairs.
   http://www.carexa.com
CRID Pharma - CLIPA Open in a new browser window  
   Design and conduct pharmaceutical and clinical studies and also prepare marketing approval files for drugs, cosmetics, dietetic products and medical devices.
   http://www.cridpharma-clipa.com/
Octagon Research Open in a new browser window  
   Using an electronic submission system (eSub), Octagon assists clients in the achievement an approved regulatory submission.
   http://www.octagonresearch.com
Regulatory Affairs Consultants to Pharmaceutical, Medical Device, Nutritional and Healthcare Industr Open in a new browser window  
   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
AnyCare-Pharmaceutical Consultant in China Open in a new browser window  
   Provide services on Market Research and Strategic Planning, Licensing, Merger and Acquisition, Regulatory Affairs, and policy consulting in China.
   http://www.anycare.com.cn
SMB Validation and Compliance Services Group Open in a new browser window  
   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/