PMA Submission Guide: FDA Requirements, Timelines, and Best Practices
For medical device manufacturers, the Premarket Approval (PMA) process is the most rigorous path to market in the...
3/20/24: Compliant Trial Master File Management & Migration in 2024
A live panel discussion hosted by Fierce Pharma, featuring a case study from Elevar Therapeutics and industry best practices from Halloran Consulting Group
Additional Kivo Resources
Biologics License Application (BLA) Guide For Life Sciences Teams
A Biologics License Application (BLA) is one of the most critical milestones in the development of a biologic therapy....
ANDA Application Guide For Modern Life Sciences Teams
Generic drugs play a critical role in improving patient access and reducing healthcare costs. But bringing a generic to...