Outwater Regulatory Consulting, LLC

Regulatory expertise for today's pharma/biotech challenges



  • Strategic regulatory consultation
  • Due diligence:  product and company acquisition
  • FDA meetings-strategy, briefing packages, conduct of meetings and negotiations
  • Regulatory Gap Analyses
  • Promotion and Advertising-regulatory strategy/opinion/review of launch and post-launch materials, ongoing copy review services
  • Drug, device, and combination product development  strategies
  • Product launch strategy/support
  • Interpretation of regulations, guidelines, position papers
  • Health Care Compliance-HCC program construction based on OIG framework, sales training programs
  • IND/NDA and Device- planning/preparation/review services
  • Retainer services for ad hoc regulatory Q&A
  • Regulatory Training

Please contact us if you do not see a specific service that meets your needs.  We may be able to accommodate your project.