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Pharmaceutical Development Group

Pharmaceutical Development Group
Pharmaceutical regulatory consultants
Joined: August 18th, 2020
Articles Posted: 2

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  • 510(k) submission - Put simply, a 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective (substantially equivalent), to an already legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA
  • FDA fast track designation - It has been my experience that even the most experienced drug development and pharmaceutical consultants will stumble over the definitions of, and differences between FDAs four expedited programs.
  • Medical device consultant -
  • Pharma consulting - Pharmaceutical consultants
  • Pharmacovigilance consultants - Role of Pharmacovigilance consultants is the recognition of drug or device risks, whether caused by quality defects, by intrinsic toxicity of the product, by idiosyncratic reactions of the individual, or by off-label use.
  • Regulatory consulting - As FDA regulatory consultants since 1999, PDG is continuously engaged with FDA in meetings and negotiations on behalf of our clients.


What is the importance of 505(b)(2)?

Posted by pharmaceuticaldevelopmentgroup - Posted 1 Year Ago

Why choose a Regulatory Affairs Company online?

Posted by pharmaceuticaldevelopmentgroup - Posted 1 Year Ago