- Acerna Inc.
GMP consultancy in Canada, assisting global pharmaceutical, biological, medical device, natural health products, and cosmetics companies with manufacturing or regulatory compliance issues.
http://www.acerna.ca
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- Aclairo
Aclairo is a drug development consultancy, based in the Washington DC area, focusing on preclinical toxicology, pharmacology, regulatory affairs issues, and U.S. Agent services to non-U.S. biopharmaceutical companies.
http://www.aclairo.com
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- Alenpharm
Offering qualified services for the initial registration and re-certification of medical supplies, biologically active additives, and medications to sellers and manufacturers of these products.
http://www.alenpharm.com
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- AQA Co.
Offering ISO 13485 and FDA QSR (21 CFR 820) Quality Manual and Operational Procedures and forms. Free software demo downloads available.
http://www.isoxp.com/
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- Arazy Group
Medical device consultant providing manufacturers with market approval, clinical evaluation, FDA Clearance as well as evaluation from public health authorities. Offices in London, UK and Buenos Aires. Argentina.
http://www.arazygroup.com
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- ARX
21 CFR Part 11 compliant digital and electronic signatures for any file format, document system, or web application.
http://www.arx.com
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- ARx Pharma, Inc.
Provide scientific and regulatory CMC consulting services to the global pharmaceutical and biopharmaceutical industry through strategic design and implementation of different aspects.
http://www.arxpharma.com/
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- ASG Inc.
Clinical Consulting: Specializing in regulatory affairs, sas programming, biotechnology careers, data management companies, staffing pharmaceutical, consulting, statistics, biotechnology, sas, and cro.
http://www.asg-inc.com
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- Atubra Inc.
Atubra provides a full range of consulting services to FDA regulated industries including drug, medical device, cosmetic, and dietary supplement companies.
http://atubra.com
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- BesTech
Consulting services guides medical companies through the FDA and CE compliance processes to ensure their business success. Provide solutions for regulatory compliance, product safety, litigation support and design and development of medical devices.
http://www.bestechconsulting.biz
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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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
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- Ceutical Labs
Provide infrastructure to small to medium sized businesses in pharmaceutical, medical device, nutraceutical, pet, and cosmetic industries, including product development, project management, validation, quality, regulatory affairs, IT, sales, and marketing.
http://www.ceuticallabs.com
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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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
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- CMAC Consultancy
Provides services like documentation and change control, validation and qualification execution, calibration and preventive maintenance, GXP training and implementation, project administration and commissioning, as well as, IT services/operation management.
http://www.cmacusa.com
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- Comply
Software packages for quality assurance processes such as management of the documentation center, employee training records, environmental monitoring, deviations, CAPA, stability studies, and trends analysis.
http://www.comply.co.il
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- Cro.nu
CRO in drug development process in close collaboration with the preclinical and clinical departments of pharmaceutical and biotech companies.
http://www.cro.nu
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- Diapharm
German consulting firm assists pharmaceutical and healthcare companies with regulatory matters relating to drugs, medical products, nutritional supplements, biocides, and cosmetics.
http://www.diapharm.com
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- Doctor Device
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/
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- elc group
Regulatory affairs company with its HQ in Prague, Czech Republic assisting pharmaceutical and related industries with product registrations, GMP inspections, medical writing, clinical research/trials, bioequivalence studies. Regulatory services offered all EU languages.
http://www.elc-group.com
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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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
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- 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
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- FDALive.com
Live broadcasting of FDA meetings via video-conferencing, webcasting and audio-conferencing. Post-meeting webcasts, DVD, CDs, videotapes and transcripts available.
http://www.fdalive.com/
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- HDM Corp.
Offers Internet-based HIPAA privacy and confidentiality training software for payers, providers and academia as well as HIPAA-compliant medical billing software for providers.
http://www.hdmcorp.com
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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- IDEC Validation Ltd
Provider of Quality and Compliance services to the Pharmaceutical / Biotechnology sector. Primarily assist organisations in the CSV field satisfy Regulatory and Compliance requirements. IVL has field knowledge in the implementation of compliance solutions.
http://www.idecvalidation.com/
(Added: Mon Apr 04 2011 Hits: 0 Rating: 0.00 Votes: 0)
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