The U.S. remains the largest biopharma market globally, generating substantial revenues and profits for the industry. As a result, it is challenging to develop a successful New Chemical Entity (NCE) product without addressing the requirements for a future U.S. FDA submission.
In this webinar, Jonathan Chow from Covar Pharmaceuticals will provide an introduction to the overall concepts of Investigational New Drug (IND) applications and the Common Technical Document (CTD) format, with a focus on specific early-stage drug development requirements and expectations. The webinar will particularly emphasize Module 3 (Quality) of the CTD, covering submission requirements for drug substance and drug product details, as well as expectations for presenting relevant information and stability data for Phase I/II studies.
* Covar Pharmaceuticals specializes in development of sophisticated dosage forms for small molecules, including bioavailability or solubility enhancement, modified and targeted delivery, and drugs requiring sophisticated delivery systems or manufacture processes.
