News & Insights

Potency Assays

On this episode of Insight at Biologics, HeeSun Smaldore, Business Unit Lead, shares some helpful thoughts about the intricacies of deciding when to hire an outside consultant.

On this episode of Insight at Biologics, Senior Consultant Dr. Emily Noonan Place from Biologics Consulting chats with James Taylor about IND submissions. The fact is that the regulatory agency doesn't get a lot of time with your IND submission. How then does one make the most of that time?

How does one know if you may have all the correct information for making a drug or device submission? A gap analysis from experienced experts can actually save you time and money! David Pepperl explains more in this episode of Insight at Biologics.

Using your own cells to help you heal isn't science fiction anymore. Robert Kutner takes us into the exciting world of in vivo cell therapy.

Bringing a drug or device to market can be arduous. In this interview with Debra Barngrover of Biologics Consulting, we learn how a consultant can help bring your picture into focus.

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…