PIV Product Launch Strategies

Our experts are industry leaders with experience in pre and post Life Cycle Management and Loss of Exclusivity (LOE) strategies of innovator (branded) pharmaceutical products, as well as launching PIV and 505B-2 products.

Key Areas of practice include:

  • Supply Chain
  • Distribution
  • Contract Manufacturing
  • Packaging
  • Pricing
  • Marketing Strategy
  • Authorized Generics
  • 505-b-2
  • Sarbanes-Oxley Act compliance for the Managed Care
  • Government and Guaranteed Pricing Contracts
  • Market access compliance
  • Market access contracts with Pharmaceutical Benefit Managers (PBMs) and Health Management Organizations (HMOs)
  • Clinical Studies
  • ANDAs
  • Bioequivalency studies
  • Patent Valuation
  • Product and Technology Licensing