One-Way Ticket to Commercial Launch: What to consider for drug synthesis, clinical trials, and regulatory filing
Preparing for a successful commercial launch starts long before FDA approval. This seminar will outline what drug synthesis, clinical logistics, packaging design, and regulatory considerations should be considered for commercial launch. This includes:
• The importance of route scouting and development while getting the drug registered and validated
• Avoiding the edge of failure in the drug synthesis process
• Transitioning from clinical to commercial: safety & efficacy data, packaging design,
• A review of the Investigational New Drug (IND) application and the FDA’s marketing authorization process, including common areas that are underestimated
• The packaging design, logistical and regulatory steps needed to flourish under expedited FDA programs (i.e. Fast Track, Breakthrough, Accelerated Review, etc).
Afterwards, join the speakers for lunch and networking.