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:

  • Analysis of Pharmaceutical Antitrust Litigation
  • 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