Article
Regulatory Requirements for Biologic Drug Development
Author(s):
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.
Newsletter
Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.
Related Videos
Related Content
