
News & Insights

“What is Ex Vivo Gene Therapy, and What Regulatory Challenges do Developers Face?” Featuring Robert Kutner
Using your own cells to help you heal isn't science fiction anymore. Today, we’re diving deep into the exciting world of ex vivo cell therapy with Robert Kutner of Biologics Consulting, exploring exactly what ex vivo cell therapy is, how it helps fight rare diseases and cancer, and the regulatory disadvantages that producers face.

“How a Consultant can Support Your Regulatory Compliance with a Gap Analysis” Featuring Dr. Debra Barngrover
Bringing a drug or device to market can be arduous. There are so many difficulties that can arise, from ensuring safety and efficacy with GMP, to navigating regulatory compliance. In this interview with Debra Barngrover of Biologics Consulting, we learn how a consultant can help bring your picture into focus through a gap analysis and other strategic approaches.

Biocompatibility Nuances And Its Impact On Medical Devices
Biocompatibility can be challenging and frustrating when developing a medical device. Why do you have to spend time and money to do the same testing, if the materials used in your device have already been tested, approved, and put in medical devices on the market? Biocompatibility impacts the majority…