hourglass suggesting NDA timeliness for early phase studies

Case Study: Proactive Strategies for Meeting NDA Timelines Despite Last-Minute Supplemental Study Requests

On-time NDA submission success story


Lona Sheeran | Sherilyn Adcock, RPh, PhD

Five last-minute studies were accommodated, executed, analyzed, and properly documented for successful NDA submission to the FDA and EMA in just 8 months. Read the full case study here.

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Lona Sheeran
Meet the author

Lona Sheeran

Senior Vice President, Clinical Operations Early Phase
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Sherilyn Adcock, RPh, PhD
Meet the author

Sherilyn Adcock, RPh, PhD

Chief Scientific Officer, Early Phase Development
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