Regulatory and Consulting

The regulatory pathway for dermatological products, in particular topically applied products, differs from those for other therapeutic indications and dosage forms. Early development of proper strategies can shorten timelines and reduce costs. bioskin® can help you develop specific strategies and collaborate with you throughout all stages of the development process which can speed development from candidate selection through regulatory approval all while managing risks.

Our strategic consulting and regulatory services include:

  • Regulatory Strategy
  • Preparation/Review of Regulatory filings
    • (IND, NDA, 505(b)(2), ANDA, MAA, Annual Reports, Combo product, Ophan Drug and Fast Track designations)
  • Preparation/Review of Regulatory Authority briefing packages and meetings
    • (pre-IND, End-of-Phase 2, pre-NDA FDA meetings, Scientific Advice and Protocol Assistance, etc.)
  • Attendance and client representation at agency meetings
  • Regulatory intelligence and guidance interpretation
  • Life-cycle management
  • US Agent representative services