• Advising on FDA-regulated matters for initial and follow-on public offerings, mergers and acquisitions, and internal investigations
  • Developing and revising contract templates for various clinical agreements including clinical trials, investigator initiated studies, and registries
  • Advising on GxP compliance issues, including Good Clinical Practices and Good Manufacturing Practices, relative to clinical trials of investigational and commercial products
  • Updating and revising compliance program policies consistent with FDA and HHS-OIG requirements, industry guidelines such as the AdvaMed Code and PhRMA Code, and state-level compliance considerations
  • Providing strategic advice on various other matters including Laboratory Developed Tests, FDA marketing application submissions (NDAs, BLAs, 510(k)s), ClinicalTrials.gov registration and compliance, pharmacovigilance and adverse event reporting, advertising and promotion issues, and the Drug Supply Chain Security Act