Regulatory Services

Jeiven Pharmaceutical Consulting, Inc. (JPC) offers guidance on:

  • Drugs, devices, biologics, and combination products
  • Pre-IND or Pre-IDE briefing documents
  • Design and/or review of toxicology studies
  • Preparation and/or review of CMC sections
  • IND, NDA, ANDA, ANADA, PMA, BLA, 510(k) submissions
  • 505(b)(2) strategies
  • Annual Product Reviews (APRs)
  • Drug Master File (DMF) and Veterinary Master File (VMF) preparation and review
  • IND/NDA annual reports
  • Clinical protocol approvals
  • Mock PAI audits
  • Oversight to ensure that appropriate regulatory documentation is on file
  • Preparing for, and responding to, a regulatory inspection, (FDA, EU, MHRA, TGA, etc.)
  • Regulatory training
  • Due diligence on new product(s)/technologies for investors / licensees

Address :

6 Jacobs Lane
Scotch Plains, New Jersey 07076