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May 23, 2023  •  Podcast

Insight at Biologics – Episode #9

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.

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April 20, 2023  •  News

Dr. Emily Place to present at TIDES USA event in San Diego

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

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April 18, 2023  •  Podcast

Insight at Biologics – Episode #8

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.

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March 21, 2023  •  Podcast

Insight at Biologics – Episode 7

Institutional Memory

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March 7, 2023  •  Podcast

Insight at Biologics – Episode 6

Potency Assays

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February 9, 2023  •  Podcast

Insight at Biologics Episode 5

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.

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January 19, 2023  •  News

Kenneth Guito, COO, named a Top 25 Healthcare Technology Leader of Virginia for 2023

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.

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January 10, 2023  •  Podcast

Insight at Biologics Episode 4

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?

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January 4, 2023  •  Blog

Tips for working with the FDA eStar form

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

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December 13, 2022  •  Podcast

Insight at Biologics Episode 3

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.

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