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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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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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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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August 19, 2022  •  News

Nonclinical Business Unit Meeting

The Biologics Consulting Nonclinical Business Unit had a productive team meeting on August 3rd and 4th at the Alexandria Headquarters. After some general company discussions and updates, the team launched into strategic planning sessions for the upcoming year and Dr. Emily Noonan-Place provided some…

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August 4, 2022  •  News

CMC Business Unit Welcomes Vidhya Mathiyazhagan

Biologics Consulting is pleased to welcome Vidhya Mathiyazhagan to the CMC Business Unit. Vidhya comes to us from Bluebird Bio with more than 10 years of experience in biologics QC and analytical development.  Vidhya is a CMC Technical Writer with past experience in authoring submissions for FDA, EMA…

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July 25, 2022  •  News

Regulatory Project Management Business Unit Meeting

The Biologics Consulting Regulatory Project Management Business Unit had a productive team meeting on July 14th at the Alexandria Headquarters office. They were able to nurture their collaboration as a business unit, focus on areas of team and personal improvement, create deliberate dialogue related…

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June 17, 2022  •  News

Biologics Consulting welcomes Rita Wilson, MS to project management team

Biologics Consulting is pleased to welcome our newest Regulatory Project Manager (RPM), Rita Wilson, MS to our project management team. She joins us from sunny San Diego, CA with 14 years of clinical and global regulatory experience in various therapeutic areas. Recently, she was a Senior Manager at…

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June 7, 2022  •  News

Biologics Consulting Adds CMC Expert Robert Kutner To Growing Team

We welcome Robert Kutner as a new addition to the CMC Business Unit at Biologics Consulting this week! Robert is a technical and regulatory expert in cell and gene therapy process and analytical development. Robert comes to us from Avrobio, Inc., where he was Head of Process and Analytical Development…

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May 31, 2022  •  News

Biologics Consulting Welcomes Jenny Xiradakis, B.Sc. Pharm to its CMC Business Unit

Biologics Consulting is pleased to welcome a new member to our CMC Business Unit - Quality and Compliance Group, Ms. Jenny Xiradakis, B.Sc. Pharm. Jenny joins Biologics after 16 years at FDA (CDER), Office of Pharmaceutical Quality/Office of Surveillance, and the Office of Regulatory Affairs, New York…

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