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Drumbeat Dimensions Inc.
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.
Regulatory consulting firm assisting medical device, biologic, pharmaceutical, and biotech manufacturers meet US and international regulatory requirements.
http://www.bioreg.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.
http://www.horizonphoenix.com
Medical Devices Consulting
Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting services.
http://www.qsrhelp.com
Comprehensive Solution Affiliates
HIPAA consulting and solution packages.
http://www.csa-hipaa.com
21 CFR Part 11 Compliance Resource
A resource for issues surrounding the FDA's 21 CFR Part 11 Rule on electronic records and signatures.
http://www.21cfrpart11.com
Hippa Custom
HIPAA compliance, training, and assessment.
http://www.hipaacomplianceregulationtraining.com
New World Regulatory Solutions/SOOP International
Regulatory, quality and technical affairs guidance for international medical diagnostic device manufacturers.
http://soop.us
ATC Corp. - American Technical Consultants
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
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
Online training for HIPAA compliance for insurance professionals.
http://www.bytesizelearning.com/hipaa.htm
Pensa Technology Solutions Inc.
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
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
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"
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.
Provides international regulatory solutions to the pharmaceutical and biologics industries.
http://www.regintel.com
Lewis CMC Consulting
Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic, dossier preparation, and training services.
http://www.lewiscmc.com
QRC Associates
QRC Associates provides management with cGMP and QSR advice.
http://www.qrcassociates.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
Lubin Consulting Inc.
Integrates cost-effective customized solutions, workflows, design controls and product development processes into medical device designs.
http://www.lubinconsulting.com
QCT Solutions, LLC
Specialities include cGMP systems, for cause audits, and PAI preparation.
http://www.qctsolutions.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/
Smith and Associates
A consulting firm specializing in regulatory affairs for medical device manufacturing.
http://www.fdaconsultants.com/
ISOComp, Inc.
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
Specialized due diligence services for venture capital and licensing opportunities in the life sciences industry.
http://pages.ivillage.com/germainegross/
GMP Online Consultancy
European-based, Good Manufacturing Practice (GMP) Online Consultancy
http://www.gmp-online-consultancy.com
Medical Device Technology Consultants - Cambridge UK
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
RAA (regulatory affairs consultancy)
http://www.regaffairs.net
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
21 CFR Consulting
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
Compliance for electronic record management for FDA regulated companies.
http://www.adneurope.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, pharmacogenomics, analyte specific reagent (ASR) regulatory compliance, and proteomics), medical device software (including bioinformatics), CPT coding reimbursement, and biotechnology-based products.
http://www.biotech-consultant.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/
Doctor Device Consultant
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
Providing a wide range of consulting services in GCP, GLP and GMP compliance.
http://www.brandtconsulting.us
Marion Weinreb and Associates, Inc.
Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries meet compliance and development needs.
http://gmpsrus.com
Validation Technologies, Inc.
Worldwide validation, quality, compliance, and production services for the medical device, pharmaceutical, nutraceutical, and biotechnology industries.
http://www.validation.org/
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/
GMG BioBusiness
UK based product development service company providing strategic support and regulatory affairs resources.
http://www.gmgbio.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
Critical Path Consultants, LLC
Provides customized consulting services including quality system, process validation, or compliance-related (ISO, FDA, CE mark) issues, as well as R&D, design, and product testing.
http://www.criticalpathconsultants.com
GMP Experts
Offer analysis, development, documentation, validation, support and assistance to industries regulated by FDA and similar international agencies.
http://www.gmpexperts.com/
Computer Validation Resource Center
A web site dedicated to Computer Validation in the Pharmaceutical industry.
http://www.gentweb.net
Tarius Interactive
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
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
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
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
Provides Members with searchable databases as well as full text searching of regulatory compliance topics.
http://FDACompliance.Net
Medical device consultants
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
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
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.
http://www.idecvalidation.com/
AQA
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
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 preparation of responses to FDA compliance actions.
http://www.biologicsconsulting.com
Computer Validation Services & 21 CFR Part 11
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"
http://www.osrsolutions.com/osr_solutions.html
MedFO, Inc. - Medical Information Communication Consulting
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
Carexa's experienced consultants provide strategy and services for drug development and regulatory affairs.
http://www.carexa.com
CRID Pharma - CLIPA
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
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
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
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
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/
MDI Consultants
A quality assurance, regulatory, and clinical consulting firm providing services to the medical device, pharmaceutical and food industries.
http://www.mdiconsultants.com
Lorentzson FDA Consulting Services, FDA Publications and Forms
Helping with the U.S. FDA regulation, compliance and approval process, including GMP, DMF, QSR, ANDA, audit and the related publications and forms.
http://www.clorentzson.com/
Directory of information for pharmaceutical regulatory affairs
reg-info.com is a personal collection of links to important sites relating to pharmaceutical regulatory affairs
http://www.reg-info.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
DocLife
Business process management (including 21 CFR Part 11 compliance).
http://www.doclife.net
Clinical Device Group Inc.
Clinical Device Group offers full CRO services for medical devices manufacturers.
http://www.clinicaldevice.com
FDALive.com
Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CD's, videotapes and transcripts available.
http://www.FDALive.com
Aitheras, LLC.
Offers validation, ERP/CRM, testing, and enterprise effeciency services for medium and large scale organizations from Rockville, Maryland.
http://www.aitheras.com/
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
BesTech regulatory consulting
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.
http://www.bestechconsulting.biz
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 partner search.
http://www.medicaldeviceconsultancy.co.uk
Jouhou Koukai Services
Provider of pharmaceutical development, regulatory and business intelligence information on the Japanese pharma and medical device market.
http://www.jouhoukoukai.com
Global Regulatory
Pharmaceutical, medical device, biotechnology, food, and nutraceutical consulting for the international markets.
http://www.GlobalRegulatory.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
BuzzeoPDMA, Inc.
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)
http://www.buzzeopdma.com
Aquasol Solutions. Inc.
Aquasol Solutions, Inc. is a professional Drug Regulatory Affairs consulting firm, providing regulatory solutions to drug manufacturing and registration problems.
http://aquasol-solutions.com
Mock-FDA-Inspections
Pharmaceutical Compliance Services, Inc. prepares domestic and international pharmaceutical manufacturing sites for FDA Regulatory Pre-Approval Inspections (PAIs) and routine FDA inspections. PCS specializes in providing “Quality Systems†audits and cGMP gap analysis/risk assessment guidance.
http://www.Mock-FDA-Inspections.com
Applied Regulatory Consulting
Applied Regulatory Consulting Limited provides regulatory consultancy to the pharmaceutical industry, including strategic regulatory consultancy, project management, training, regulatory agency interactions and regulatory submissions.
http://www.appliedregulatory.com
HIPAAdirect
A directory of HIPAA links
http://www.hipaadirect.com/
European Authorized Representative
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/
The Arazy Group
Medical Device RA and Quality System Consultants
http://www.arazygroup.com
KAI
Regulatory and validation service provider.
http://www.keiperassoc.com
Regulatory Affairs Consulting
Regulatory affairs consulting services to the pharmaceutical and related industries.
http://www.newdrugapprovals.com
Validation Masters, Inc.
Company serving the pharmaceutical manufacturing and clinical research industries.
http://www.validationmasters.com/
Ehrreich Consulting, Inc.
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
Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing and testing companies worldwide.
http://www.CodaCorpUSA.com
Liquent, Inc.
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
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
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.
http://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
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
HIPAA and OIG Compliance Plan for Doctors
Health care providers compliance plan for doctors for HIPAA and OIG compliance regulations and chart audits.
http://www.complianceplanfordoctors.com
Compliant Projects Ltd.
Independent provider of FDA compliance, validation, GxP, quality and project management services to the pharmaceutical industry.
http://www.compliantprojects.co.uk/
MedPharmTec Services
German consultant for the pharmaceutical industry.
http://www.medpharmtec.de
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
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
Westerwald-Institute
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
European medical device regulatory consultant
http://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.
http://www.reg123.com
The Matthews Consultancy
European pharmaceutical/biotech consultancy specializing in project management, medical writing, and business development.
http://tmconsultancy.com
Newland GxP Consultancy
European pharmaceutical GxP Consultancy.
http://www.newland-gxp.co.uk
Regulatory Affairs, North America LLC
Regulatory affairs consultancy headquartered in North Carolina.
http://www.ranallc.com
Milestone Biomedical Associates
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
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
http://www.validationassociates.com
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