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
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