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  Regulatory Affairs (182)

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Kobridge Consulting Ltd Open in a new windowLink Details
- Korean consultants to medical device companies for CE marking, Canadian approvals, and FDA compliance.
- http://www.kobridgeconsulting.com

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Mandell Horwitz Consultants LLC Open in a new windowLink Details
- Regulatory and scientific consulting for medical devices and other FDA-regulated products.
- http://mandellhorwitzconsulting.com

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Cabridge Regulatory Services Open in a new windowLink Details
- Specialists in the field of pharmaceutical regulatory affairs.
- http://www.cambreg.co.uk

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21 CFR Part 11 Compliant Solutions Open in a new windowLink Details
- Document, drawing & spreadsheet management solutions for US FDA compliant pharma manufacturing units
- http://www.part11solutions.com

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Tecno-med Ingenieros Open in a new windowLink Details
- Located in Barcelona, Spain - helps manufacturers to obtain CE mark for their medical devices.
- http://www.tecno-med.es/

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SimPILy Read Open in a new windowLink Details
- Offers patient information leaflet readability tests, compliance reviews and advice on leaflet improvement for international pharmaceutical and traditional herbal medicines industries.
- http://www.simpilyread.co.uk/

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FL Quality Associates Open in a new windowLink Details
- Provide HIPAA certification, procedures manuals for medical facilities, and other administrative services for medical providers.
- http://flquality.com

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RS Consultant Services Open in a new windowLink Details
- Offering consulting services to Canada and USA in dealing with regulations for medical devices and pharmaceuticals.
- http://www.rsconsultantservices.com/

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Strategic Compliance International, Inc. Open in a new windowLink Details
- SCI, Inc. specializes in regulatory compliance consulting for biologics, medical devices and drug companies.
- http://www.sci-nc.com

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QSite Open in a new windowLink Details
- Qsite is a consulting group focused on the medical device industry. Services include advice on international regulatory affairs, clinical affairs, biostatistics, and global quality assurance.
- http://www.qsitemed.com

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A. Arham Associates Open in a new windowLink Details
- Pharma regulatory affairs consultants based in New Delhi, India for the department of DCGI - Drugs Controller General of India - & NPPA - National Pharmaceutical Pricing Authority.
- http://arhamconsultants.com

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TDC Software Open in a new windowLink Details
- TDC Software is an engineering software suite covering risk management.
- http://www.tdc.fr/en/products/tdc_fmea.php

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Draco Associates Ltd. Open in a new windowLink Details
- Draco Associates offers regulatory affairs consulting and quality assurance consulting and services for pharmaceuticals, natural health products, and other regulated products.
- http://www.dracoassociates.com

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Pharmaceutical Development Group Open in a new windowLink Details
- Dr. Cheryl Blume and staff provide pharmaceutical and FDA regulatory consulting services including, but not limited to, development of pharmacovigilance assessment programs, pharmacokinetic protocols, non-clinical protocols and preparation for GCP/GLP and
- http://www.pharmdevgroup.com

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DRW Research & Information Services, LLC Open in a new windowLink Details
- Provides regulatory affairs research and information for the healthcare industry.
- http://www.drw-research.com

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ARx Pharmaceutical Regulatory Consultancy LLC Open in a new windowLink Details
- 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/

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TRAC Services Open in a new windowLink Details
- A UK based company providing regulatory affairs consultancy and patient information leaflet user testing to the pharmaceutical industry.
- http://www.tracservices.co.uk/

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ComplianceFDA, Inc. Open in a new windowLink Details
- FDA warning letter and CFR categorization and search database.
- http://www.complianceFDA.com/

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Ceutical Labs Open in a new windowLink Details
- 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

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PinneyAssociates Open in a new windowLink Details
- Pinney Associates brings science and public health expertise to pharmaceutical, consumer healthcare, and biologics clients in risk management, over-the-counter switch, and marketing strategy.
- http://www.pinneyassociates.com/

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GCP Solutions Open in a new windowLink Details
- GCP Solutions provides good clinical practice consulting services.
- http://mysite.verizon.net/sisbill1/gcp.htm

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Leonard Steinborn Consulting, LLC Open in a new windowLink Details
- Provide FDA related regulatory submission, training, auditing and consulting services.
- http://www.leonardsteinbornconsulting.com

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Lionpharm Regulatory Consulting GmbH Open in a new windowLink Details
- Lionpharm is an independent consultancy company providing all kind of regulatory affairs services covering the whole life-cycle of medicinal products in Europe.
- http://www.lionpharm.com

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Kemic Bioresearch Open in a new windowLink Details
- Kemic Bioresearch provides consulting, research and training in the pharmaceutical sciences (pharmacokinetics, pharmacology and toxicology).
- http://www.kemic.com

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European Pharmaceutical Consultants Open in a new windowLink Details
- European Pharmaceutical Consultants (EPC), s.r.o. provides consulting services to pharmaceutical regulatory affairs professionals in the European Union.
- http://www.pharma-eu.com

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Gamp Forum Open in a new windowLink Details
- Bio-Pharma professionals forum.
- http://www.gampforum.com

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Comply Open in a new windowLink Details
- 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

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Qserve Group Open in a new windowLink Details
- Qserve® Group B.V provides CE Marking, quality management system implementation and auditing of ISO 13485, (pre)clinical evaluation, product market approval (e.g. CE/EU and FDA/USA) and production registration as well as other regulatory services.
- http://www.qservegroup.com/

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Quality Vectors Open in a new windowLink Details
- Provide validations, cGxP compliance, systems engineering, and quality systems to pharmaceutical, medical device, and biotechnology industries.
- http://www.quality-vectors.com

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PAT toolkit Open in a new windowLink Details
- Provides information on the FDA’s Process Analytical Technology (PAT) Initiative and outlines a software package to help pharmaceutical manufacturers implement this initiative.
- http://www.pattoolkit.com

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Q-NET LLC Open in a new windowLink Details
- EU authorized representative service in accordance with the EU medical device directive and EU machinery directive. Also act as FDA US agent for foreign establishments.
- http://www.ce-authorizedrepresentative.eu

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R. A. Q .A. Associates Open in a new windowLink Details
- R.A.Q.A. Associates provides FDA and ISO related consulting services to medical device and pharmaceutical companies. We specialize in helping firms with regulatory and cGMP problems, constructing and implementing entirely new quality and regulatory system
- http://www.raqaassociates.com

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Regulatory Bureau "Cratia" Open in a new windowLink Details
- Consulting and active assistance in registration (regulatory affairs) and clinical trials of medicinal products, API's, supplements, and medical devices in CIS countries (Ukraine, Russian Federation, Kazakhstan, Moldova, Byelorussia).
- http://www.bureaucracy.com.ua

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Samarind Regulatory Management Software Open in a new windowLink Details
- Samarind RMS is a software package for the pharmaceutical industry that manages regulatory affairs and licence submissions.
- http://www.samarindrms.co.uk

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nFocus Technologies ERP for Life Sciences Open in a new windowLink Details
- nFocus Technologies has developed a portfolio of software solutions to meet the unique requirements of this highly regulated industry.
- http://www.nfocustechnologies.com/industry-solutions/life-sciences-erp-solution.asp

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HIPAA Training & Compliance Consulting Open in a new windowLink Details
- Provides HIPAA training, compliance kits, manuals, disaster recovery & business continuity templates and compliance consulting services.
- http://www.training-hipaa.net

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Cro.nu Open in a new windowLink Details
- CRO in drug development process in close collaboration with the preclinical and clinical departments of pharmaceutical and biotech companies.
- http://www.cro.nu

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Validation in Partnership Ltd Open in a new windowLink Details
- Specializing in the provision of validation and CGMP (Current Good Manufacturing Practice) compliance services.
- http://www.vipltd.co.uk

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Corporate Consulting Enterprises, LLC Open in a new windowLink Details
- Provide mock audits, quality systems assessments, and liaison services with the FDA.
- http://fdaperspective.com

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ARX - Digital Signature Solutions Open in a new windowLink Details
- 21 CFR Part 11 compliant digital and electronic signatures for any file format, document system, or web application.
- http://www.arx.com

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PRI Group Open in a new windowLink Details
- Provides specialist advice for regulatory strategy in Europe.
- http://www.pri-group.com

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