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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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November 22, 2022  •  Podcast

Insight at Biologics Episode 2

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.

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November 17, 2022  •  Blog

Connected Medical Devices and Public Cloud Services

Public cloud computing services are being increasingly used by medical device manufacturers to house components of medical device software. In this post, I am referring to a public cloud as defined by NIST SP 800-145:2011, The NIST Definition of Cloud Computing, and their “platform-as-a-service (PaaS)”…

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November 16, 2022  •  News

Deltek MVP Award – Professional Services Category!

Way to go Team! We are thrilled to announce that Biologics Consulting is a 2022 Deltek MVP Award winner in the Professional Services Category! We accepted our award at #DeltekProjectCon in front of 3,000+ customers for our upgrade to Deltek Vantagepoint to further modernize our software tools…

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November 1, 2022  •  Podcast

Insight at Biologics Episode 1

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.

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October 13, 2022  •  News

CMC Business Unit Meeting

In late September, the Biologics Consulting CMC Business Unit met at the Alexandria Headquarters for an all-day team meeting. The meeting created some insightful discussion that focused on the overall CMC strategic plan and growth initiatives as well as broader company updates. After a productive meeting…

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September 20, 2022  •  News

Biologics Consulting attends RAPS Convergence

Some of our Biologics team had a good experience attending this year's RAPS Convergence conferences in Phoenix, Arizona. They met with some current clients and made some introductions with some companies in need of regulatory support. The team enjoyed the opportunity to be back in person to share…

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