Regulatory Requirements for Biologic Drug Development

Article

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.

Subscribe Now!
Recent Videos
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
Behind the Headlines, Episode 18
Drug Digest: Patient Preference Drives Solid Dosage Trends
Behind the Headlines, Episode 17
Related Content
3d render, number six glowing in the dark, pink blue neon light | Image Credit: © NeoLeo - stock.adobe.com

The 6-Stage Compounding Framework Every Pharmaceutical Manufacturing Professional Should Know

Christopher Cole
July 17th 2025
Article

A structured, risk-based framework for pharmaceutical compounding that enhances quality, regulatory compliance, and process consistency.

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Brain Injury, Blood in Injured Brains (stroke, brain hemorrhage, intracerebral hemorrhage, subarachnoid hemorrhage, arteriovenous malformation, brain aneurysm rupture, traumatic brain injury) | Image Credit: © Arugula Pica - stock.adobe.com

Generative AI-Driven Collaboration to Research Treatments for Brain Hemorrhage Complications

Patrick Lavery
July 9th 2025
Article

Delayed cerebral ischemia is a leading complication in the severe form of stroke known as subarachnoid hemorrhage and can result in long-term neurological damage, disability, or death.

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

Bone structure 3d illustration, normal and with osteoporosis | Image Credit: © adimas - stock.adobe.com

Theramex Treatment for Osteoporosis in Postmenopausal Women Accepted by Scottish Medicines Consortium

Patrick Lavery
July 7th 2025
Article

The company estimated that more than 1000 women in Scotland at very high risk of fracture would be eligible for treatment.

Document Review and Quality Control Concept. Document with a checkmark, quality assurance, and process control. auditing, compliance, verification, data inspection, and business workflow management. | Image Credit: © Supatman - stock.adobe.com

A Novel, Enhanced, and Sustainable Approach to Audit Trail Review

Diana Russo
July 4th 2025
Article

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.