Need to Reformulate? Anxious About the Time and Expense of Additional Clinical Studies?
Read this case study to learn how Recro Gainesville helped a client achieve a complex reformulation and subsequent successful CMC supplement filing in less than a year.
A CMC prior approval supplement (PAS) for a reformulated pharmaceutical under the FDA scale-up and post-approval changes (SUPAC) guidance can enable developers to:
- Save time
- Avoid millions of dollars in clinical study conduct costs
- Achieve FDA approval
Recro can help pave the way for your successful CMC PAS filing by simplifying and isolating proposed changes and using a risk-based scientific approach to minimize clinical impact. Then, as your partner, our scientific team will apply decades of experience and expertise to enable the rapid development of your new formulation — and help you present a confident, science-based case to your regulatory agency. Download our case study to learn more.
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