Medpoint » Drug Regulation http://www.medpoint.com Device, Pharmaceutical, Biotech Tue, 31 Jan 2012 21:44:28 +0000 en hourly 1 http://wordpress.org/?v=3.1 R.L.W. http://www.medpoint.com/raw-illinois/ http://www.medpoint.com/raw-illinois/#comments Thu, 30 Oct 2008 14:40:10 +0000 PECULIAR http://medpoint.timpecoraro.com/?p=180 Thirty-three years of experience in the medical device and combination drug/device regulation, manufacturing, quality assurance and R & D arenas.  Specialty is working on the pre-meetings and briefings with the FDA.

Titles Held: Corporate Senior Director of RA; Global Director of RA; Director of RA North America; Quality Assurance Manager; Senior Microbiologist

  • Has extensive experience in interfacing with the FDA, at the district and headquarters levels, as well as with international regulatory authorities
  • Strong international experience including international product registrations, CE mark approvals and import/export activities
  • Extensive experience with compliance issues, Warning Letters, product recalls, facility inspections and resulting 483 responses and consent decrees
  • Has obtained both PMA’s and 510(k)’s, In-Vitro diagnostics, IND, IDE, PLA and NDA approvals.
  • RAC certified with extensive knowledge with combination drugs devices
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