News & Insights

On this episode of Insight at Biologics, Bruce Pearce continues sharing his insight about the new ICH guidance which may allow you to forego animal carcinogenicity testing in favor of a weight of the evidence argument.

Biologics Consulting is proud to announce that Dr. Emily Place, Senior Consultant at Biologics Consulting, will be presenting at the upcoming TIDES USA Event.

The ICH has released a guidance which may allow you to forego animal carcinogenicity testing in favor of a weight of the evidence argument. We conclude our two-part discussion of why to do that and how to do that with Bruce Pearce.

Institutional Memory

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.

Biologics Consulting Chief Operating Officer Kenneth Guito has been named to The Healthcare Technology Report's Top 25 Healthcare Technology Leaders of Virginia for 2023.

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?

Tips and tricks for navigating the FDA Center for Devices and Radiological Health (CDRH) electronic Submission Template And Resource (eSTAR)

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.