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IVD Consultants - Services

http://www.ivdconsultants.com/services

US FDA and Global Regulatory Affairs Experts. IVD Consultants is a full-service consulting/contract firm that specializes in providing a wide range of U.S. FDA regulatory affairs services to the In Vitro Diagnostic (IVD) Device, Companion Diagnostic (CDx), Medical Device, Combination Drug/Device, Clinical Laboratory, Biological and Pharmaceutical industries. Our services include the following:. US FDA Regulatory Affairs and Global Regulatory Body Negiotiations. US FDA Warning Letter Resolution.

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IVD Consultants - Home

http://www.ivdconsultants.com/home

US FDA and Global Regulatory Affairs Experts. IVD Consultants is a full-service consulting/contract firm that specializes in providing a wide range of U.S. Food and Drug Administration (FDA) and Global Regulatory Affairs services to the In Vitro Diagnostic (IVD) Device, Companion Diagnostic (CDx), Medical Device, Combination Drug/Device, Clinical Laboratory, Biological and Pharmaceutical industries. Our services include the following:. US FDA Regulatory Affairs and Global Regulatory Body Negiotiations.

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The IVD Industry Connectivity Consortium (IICC). The potential to reduce the cost and time involved with lab device connectivity has been demonstrated with the IHE LAW Profile. As an industry, it’s time we move beyond our interoperability challenges and refocus our energy on advancing healthcare. Eric Olson, President. IICC, and Vice President, Portfolio and Product Management, Siemens Healthcare Diagnostics, Inc. Edwin O. Heierman,. Jay B Jones, PhD, DABCC. The incorporation of the LAW Profile allows fo...

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IVD Consultants - Home

US FDA and Global Regulatory Affairs Experts. IVD Consultants is a full-service consulting/contract firm that specializes in providing a wide range of U.S. Food and Drug Administration (FDA) and Global Regulatory Affairs services to the In Vitro Diagnostic (IVD) Device, Companion Diagnostic (CDx) Device, Medical Device, Combination Drug/Device, Clinical Laboratory, Biological and Pharmaceutical industries. Our services include the following:. US FDA Clinical Trial/Study Protocol Development and Execution.

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IVD Consulting is a dynamic, innovative company which provides specialist business support to small and medium-sized IVD and medical device companies. Our services include marketing and sales, business development, and regulatory support for biotechnology companies entering the European IVD and medical device market. Contact us for an exploratory discussion and let IVD Consulting guide and support your business as you enter the European IVD and medical devices market.

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