Scientific Vetting & Other Services

Medical

  • Expert vetting of scientific material and promotional review
  • FDA Advisory Committee meeting preparation
  • Advisory services
  • Scientific writing
  • Support for product and labeling activities

Regulatory

  • OPDP compliance and submissions
  • Product submissions
  • IND, NDA, ANDA, BLA filings
  • Marketing Authorization transfers
  • Orphan Drug, Fast Track application
  • Overflow work and Ad hoc projects

Legal

  • Independent legal opinion and counsel
  • Fair Market Value assessments
  • Expertise in promotional regulations
  • Temporary fill-in support for vacancies or overflow work

For an overview of Scientific Vetting,
please click below: