Opioid Reformulation For Abuse Deterrence

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.