Regulatory Requirements for Biologic Drug Development

Published on: May 21, 2021

Developing and manufacturing a therapy in a regulated environment demands careful adherence to quality practices.

In this Expert Interview with BioPharm International, Steven Lynn, executive vice-president, pharmaceuticals, Regulatory Compliance Associates, shares insight on regulatory guidances, potential stumbling blocks on the development pathway, strategies to navigate the regulatory approval process, accelerated review applications, and maintaining quality standards.