|Articles|May 21, 2021
Regulatory Requirements for Biologic Drug Development
Author(s)BioPharm International Editors
Developing and manufacturing a therapy in a regulated environment demands careful adherence to quality practices.
Advertisement
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
Stay at the forefront of biopharmaceutical innovation—subscribe to BioPharm International for expert insights on drug development, manufacturing, compliance, and more.
Advertisement
Related Content
Advertisement
Advertisement
Advertisement
Trending on BioPharm International
1
Johnson & Johnson Announces Second $2 Billion Manufacturing Facility in North Carolina
2
Generative AI and Adaptive Trials Shape Future Biotech Development
3
How FDA’s Bayesian Guidance Could Accelerate Adaptive Trial Design in Biopharmaceuticals
4
Why Biotech’s Clinical Maturity Is Driving New Partnerships and Capacity Plays
5