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FDA Pre-Submission Support

Proactive planning and communication with FDA is critical to regulatory success

It’s common knowledge that communicating early and regularly with the FDA is critical to regulatory success.
Pharmapprove team spotlight

Team Spotlight: Dr. Frank Casty

Introducing Dr Frank Casty a pulmonary/critical care physician with over 25 years of experience in the pharmaceutical industry.

Virtual FDA Advisory Committee Consultants

FDA Advisory Committees During COVID-19: When Face to Face is Not an Option

COVID-19 has made preparing for FDA advisory committee meetings more intense. The good news is that there are things you can do to set yourself up for success.

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