| Directory > Business > Business Services > Consulting > Medical and Life Sciences > Regulatory Affairs 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
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Clinical Device Group Inc.
Clinical Device Group offers full CRO services for medical devices manufacturers.
http://www.clinicaldevice.com
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DocLife
Business process management (including 21 CFR Part 11 compliance).
http://www.doclife.net
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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
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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/
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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/
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MDI Consultants
A quality assurance, regulatory, and clinical consulting firm providing services to the medical
device, pharmaceutical and food industries.
http://www.mdiconsultants.com
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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/
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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
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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
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Octagon Research
Using an electronic submission system (eSub), Octagon assists clients in the achievement an
approved regulatory submission.
http://www.octagonresearch.com
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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/
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Carexa Inc. Regulatory Consultants
Carexa's experienced consultants provide strategy and services for drug development and regulatory
affairs.
http://www.carexa.com
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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
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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
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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
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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
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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/
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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
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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
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FDACompliance.Net
Provides Members with searchable databases as well as full text searching of regulatory compliance
topics.
http://FDACompliance.Net
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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
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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/
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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
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Tarius Interactive
Tarius Interactive is a world-leading pharmaceutical regulatory intelligence and knowledge
management system based on XML architecture.
http://www.tarius.com
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Computer Validation Resource Center
A web site dedicated to Computer Validation in the Pharmaceutical industry.
http://www.gentweb.net
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GMP Experts
Offer analysis, development, documentation, validation, support and assistance to industries
regulated by FDA and similar international agencies.
http://www.gmpexperts.com/
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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
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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
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GMG BioBusiness
UK based product development service company providing strategic support and regulatory affairs
resources.
http://www.gmgbio.com/
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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/
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Validation Technologies, Inc.
Worldwide validation, quality, compliance, and production services for the medical device,
pharmaceutical, nutraceutical, and biotechnology industries.
http://www.validation.org/
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Marion Weinreb and Associates, Inc.
Assisting companies in the pharmaceutical, biotechnology, medical device, and diagnostic industries
meet compliance and development needs.
http://gmpsrus.com
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Brandt Research Consulting LLC
Providing a wide range of consulting services in GCP, GLP and GMP compliance.
http://www.brandtconsulting.us
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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
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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/
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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
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ADN - IT Compliance Expertise for FDA regulated industries
Compliance for electronic record management for FDA regulated companies.
http://www.adneurope.com
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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/
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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
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Regulatory Affairs Associates LLC
RAA (regulatory affairs consultancy)
http://www.regaffairs.net
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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/
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GMP Online Consultancy
European-based, Good Manufacturing Practice (GMP) Online Consultancy
http://www.gmp-online-consultancy.com
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The Due Diligence Group
Specialized due diligence services for venture capital and licensing opportunities in the life
sciences industry.
http://pages.ivillage.com/germainegross/
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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/
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Smith and Associates
A consulting firm specializing in regulatory affairs for medical device manufacturing.
http://www.fdaconsultants.com/
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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/
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QCT Solutions, LLC
Specialities include cGMP systems, for cause audits, and PAI preparation.
http://www.qctsolutions.com
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Lubin Consulting Inc.
Integrates cost-effective customized solutions, workflows, design controls and product development
processes into medical device designs.
http://www.lubinconsulting.com
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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
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QRC Associates
QRC Associates provides management with cGMP and QSR advice.
http://www.qrcassociates.com
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Lewis CMC Consulting
Provides pharmaceutical CMC regulatory consulting services, specializing in regulatory strategic,
dossier preparation, and training services.
http://www.lewiscmc.com
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RegIntel Ltd.
Provides international regulatory solutions to the pharmaceutical and biologics industries.
http://www.regintel.com
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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
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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
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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
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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/
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Online HIPAA training
Online training for HIPAA compliance for insurance professionals.
http://www.bytesizelearning.com/hipaa.htm
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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/
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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/
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New World Regulatory Solutions/SOOP International
Regulatory, quality and technical affairs guidance for international medical diagnostic device
manufacturers.
http://soop.us
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Hippa Custom
HIPAA compliance, training, and assessment.
http://www.hipaacomplianceregulationtraining.com
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KAI
Regulatory and validation service provider.
http://www.keiperassoc.com
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The Arazy Group
Medical Device RA and Quality System Consultants
http://www.arazygroup.com
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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
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Comprehensive Solution Affiliates
HIPAA consulting and solution packages.
http://www.csa-hipaa.com
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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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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/
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Regulatory Affairs, North America LLC
Regulatory affairs consultancy headquartered in North Carolina.
http://www.ranallc.com
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Newland GxP Consultancy
European pharmaceutical GxP Consultancy.
http://www.newland-gxp.co.uk
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The Matthews Consultancy
European pharmaceutical/biotech consultancy specializing in project management, medical writing,
and business development.
http://tmconsultancy.com
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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
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Pirovano Management
European medical device regulatory consultant
http://www.dariopirovano.com
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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
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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
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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
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MedPharmTec Services
German consultant for the pharmaceutical industry.
http://www.medpharmtec.de
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Compliant Projects Ltd.
Independent provider of FDA compliance, validation, GxP, quality and project management services to
the pharmaceutical industry.
http://www.compliantprojects.co.uk/
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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
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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
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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
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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
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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
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Liquent, Inc.
Established provider of regulatory report publishing and submission consulting services and
software for the global life sciences community.
http://www.liquent.com
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Coda Corp. USA
Regulatory compliance and validation documentation consulting for FDA-regulated drug manufacturing
and testing companies worldwide.
http://www.CodaCorpUSA.com
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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
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Validation Masters, Inc.
Company serving the pharmaceutical manufacturing and clinical research industries.
http://www.validationmasters.com/
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Regulatory Affairs Consulting
Regulatory affairs consulting services to the pharmaceutical and related industries.
http://www.newdrugapprovals.com
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Medical Devices Consulting
Regulatory affairs, quality assurance, custom software, and compliance contracting and consulting
services.
http://www.qsrhelp.com
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MDI Consultants, Inc.
FDA, IVDD, CE mark, HACCP, ISO9000, and GMP compliance consulting company for the medical device
industry.
http://www.fdaconsulting.net
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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
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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.
http://www.bioreg.com
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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
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