As the U.S. market, the largest commercial market for pharmaceutical and biologic drugs, focuses on stabilizing its supply chain of essential medicines and faces pressure on healthcare costs, there is a need for low-cost, high-quality drug therapies as well as a diversified source of supply.

This webinar will address the most important steps in a roadmap to bring biosimilar, generic, and complex generic drugs through U.S. FDA filings and into the U.S. market.

Portfolio Analysis
Which products to pursue for U.S. market entry; volume; pricing, regulatory risk, intellectual property (IP)

Quality Management Maturity (QMM)
Understanding CDER’s quality assurance framework and practices; capability gap analysis; regulatory dossier preparation

Regulatory Submission
How to interface with the U.S. FDA; Reference Listed Drug (RLD), Therapeutic Equivalence (TE), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biologic License Application (BLA); inspection readiness

Commercial Readiness
A review of material requirements planning (MRP), policies and procedures, forecasting, governance, licensing, distribution, channel strategy