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  Regulatory Affairs (182)

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Imed consultancy Open in a new windowLink Details
- QA / RA for Medical devices , CE marking and QMS management
- http://www.imedconsultancy.com

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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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Custom Business Development & Management Technology Open in a new windowLink Details
- Assists companies in biotechnology, pharmaceutical and chemical markets with business development and market analysis.
- http://www.cbdmt.com

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CATS Consultants Open in a new windowLink Details
- EU regulatory affairs and preclinical/toxicological consulting.
- http://www.catsconsultants.com

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Paul Regulatory Services Limited Open in a new windowLink Details
- A regulatory affairs consultancy based in the UK.
- http://www.paulrs.co.uk

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VTS Consultants, Inc. Open in a new windowLink Details
- Validation and regulatory consulting services for the pharmaceutical, biotechnology, and medical device industries.
- http://www.vtsconsultants.com

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Compliance Control Ltd. Open in a new windowLink Details
- Provide software products and consultancy expertise to help companies achieve compliant and validated systems.
- http://www.compliance-control.com

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Karandikar Laboratories Pvt. Ltd. Open in a new windowLink Details
- Test and calibration laboratory located in India.
- http://www.laboratorytestingindia.com

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Emergo Group Open in a new windowLink Details
- Consultants to medical device companies for CE marking, authorized representative, FDA compliance and CCC mark for China. Offices in US, Europe and Asia.
- http://www.emergogroup.com

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Sagaem Open in a new windowLink Details
- Sagaem is an Italian consultancy providing regulatory affairs and business development services to pharmaceutical companies wishing to approach the Italian market or enlarge their existing business in Italy.
- http://www.sagaem.it

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Atubra Inc. Open in a new windowLink Details
- Atubra provides a full range of consulting services to FDA regulated industries including drug, medical device, cosmetic, and dietary supplement companies.
- http://atubra.com

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eHIPAA Training Open in a new windowLink Details
- Provide online privacy and security HIPAA training for business associates, employers, hospitals, clinics and health plans.
- http://www.ehipaatraining.com

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Acerna Inc. Open in a new windowLink Details
- 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

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Loyamed Inc. Open in a new windowLink Details
- Provide consulting services in the areas of quality assurance and regulatory affairs.
- http://www.loyamed.com

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Validation Online Net Open in a new windowLink Details
- Generic downloadable documents that are cGMP compliant.
- http://www.validation-online.net

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Bryn Mawr Partners Open in a new windowLink Details
- Systems integration and delivery specialists for regulatory compliant quality management applications including CAPA, complaint, electronic submission, and document management systems.
- http://www.brynmawrpartners.com

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GCP Auditing Services Open in a new windowLink Details
- An independent consultancy providing auditing services for all aspects of clinical trials and good clinical practice.
- http://www.gcp-auditing.com

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Arvin Shroff Associates LLC Open in a new windowLink Details
- Advisor to pharmaceutical, biotechnology, medical device, food, dietary supplements, and legal companies.
- http://www.arvinshroff.com

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Regulatory Affairs Syndicator Open in a new windowLink Details
- This website syndicates material for regulatory affairs professionals. Feeds are obtained from a variety of global resources about the US Food and Drug Administration.
- http://regulatory.schwoebel.net

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PRISYM ID Compliant Barcode & Labeling Open in a new windowLink Details
- 21 CFR Part 11 validated barcode and labeling solutions for pharmaceutical and medical device manufacturers.
- http://www.prisymidinc.com

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MAPCIS Validated Labeling Solutions Open in a new windowLink Details
- FDA compliant labeling and barcode systems. Software specifically developed to achieve pharmaceutical and medical device compliance.
- http://www.mapcis.com

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Validation Systems, Inc. Open in a new windowLink Details
- We provide contract and consulting services in the following areas: validation and technical services (IQ OQ PQ protocols and validation master plans VMP), quality systems development, laboratory services, environmental monitoring, and water testing.
- http://www.validationsystems.com

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21 CFR Part 11 Compliance Software Solutions Open in a new windowLink Details
- Part 11 compliance software solutions designed for MS-Excel, MS-Word, electronic laboratory notebbook, and file replication.
- http://www.21cfrpart11compliance.com/

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THINQ Compliance Ltd. Open in a new windowLink Details
- The integration of services and software to provide competitive compliance, quality advocacy and thought leadership.
- http://www.thinqcompliance.com/

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Barnhill & Associates, Inc. - Pharmaceutical Consultants Open in a new windowLink Details
- Barnhill & Associates, Inc. is a specialty based consulting firm specializing in a wide range of scientific, laboratory, quality, and validation issues within the cGMP and GLP arena.
- http://barnhillassociates.net

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Di Renzo Regulatory Affairs Open in a new windowLink Details
- Di Renzo Regulatory Affairs is a pharmaceutical consultant aiding companies that need to register products (from medicines/dietary supplements and medical devices to cosmetics) at the AIFA and the Italian Ministry of Health.
- http://www.pharmaflash.com

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Quality Solutions Open in a new windowLink Details
- Validation Professionals, Inc. (VPI) offers a full range of validation, compliance and technical services for the pharmaceutical, biotechnology and medical device industries.
- http://www.validationprofessionals.com

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Accurate FDA Consultants Open in a new windowLink Details
- FDA compliance and regulatory consulting to help clients develop efficient and effective quality systems.
- http://www.accuratefdaconsulting.com

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Estrin Consulting Group, Inc. Open in a new windowLink Details
- ECG serves the medical device, pharmaceutical and cosmetic firms on FDA submissions, meetings and compliance related issues. Founder and President: Norman F. Estrin, Ph.D. Regulatory Affairs Certified.
- http://yourfdaconsultant.com/

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SeerPharma Open in a new windowLink Details
- SeerPharma is a professional consultancy specializing in the delivery of technical compliance and validation, QA knowledge, and GMP training solutions to the pharmaceutical, medical device and biotechnology industries.
- http://www.seerpharma.com.au

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Pharmaceutical Regulatory Affairs Italy - Di Renzo Open in a new windowLink Details
- Situated in the center of Rome. We provide regulatory services for human and veterinary medicines, mutual recognition, cosmetics, foods, medical devices, and translations.
- http://www.direnzo.biz

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Smith and Associates Open in a new windowLink Details
- A consulting firm specializing in regulatory affairs for medical device manufacturing.
- http://www.fdaconsultants.com/

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FDA Compliance Solutions Open in a new windowLink Details
- FDA Compliance Solutions' consultants provide a full range of FDA compliance services, including computer system validation, software validation, process validation, pharmaceutical validation and consulting.
- http://www.fdacompliancesolutions.com

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Innovative Consultancy Services Open in a new windowLink Details
- We are an Indian pharmaceutical consultant company established in the year 1998 and providing services in regulatory affairs, pharmaceutical dossiers, product/process development, and validation services.
- http://www.pharmaceutical-consultancy.com

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Allegheny Associates - Regulatory and Clinical Affairs Consulting Open in a new windowLink Details
- Joe Schwoebel is General Manager of Allegheny Associates. The consultancy provides services related to medical product planning, clinical study, regulatory affairs and reimbursement strategy.
- http://www.schwoebel.net

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Consultifarma Open in a new windowLink Details
- Consultoria especializada no registro de produtos e empresas sujeitas a vigilancia sanitaria, assim como em atividades que abrangem: pesquisa clinica, controle de qualidade e estabilidade, treinamento, marketing farmaceutico etc.
- http://www.consultifarma.com

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Masy Systems Open in a new windowLink Details
- Validation and calibration services for the pharmaceutical, biotech, and related fields. Information on equipment and shipper studies.
- http://www.masy.com/

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Perseus Partners Open in a new windowLink Details
- Consulting group headquartered in Belgium. They manage biosafety and biotechnology compliance requirements.
- http://www.perseus.be

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unicus regulatory services Open in a new windowLink Details
- Unicus regulatory services is a fully functional regulatory consultancy located in the UK.
- http://www.unicus.co.uk/

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CMAC Consultancy Open in a new windowLink Details
- Provides services like documentation and change control, validation and qualification execution, calibration and preventive maintenance, GXP training & implementation, project administration and commissioning, as well as, IT services/operation managem
- http://www.cmacusa.com

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FDC Services Open in a new windowLink Details
- A regulatory affairs and quality systems consulting company serving the medical device and pharmaceutical industries.
- http://fdcservices.com

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Horizon Phoenix Group Open in a new windowLink Details
- Quality/regulatory consultants for medical device, pharmaceutical and biotechnology industries. Services include: CE Marking, Authorized European Representative, USFDA, 510ks, PMAs, US Agent and Canadian Licenses.
- http://www.horizonphoenix.biz

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