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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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May 13, 2022  •  News

Biologics Consulting Expands With Addition of Dr. Emily Noonan-Place, PhD, MPH

Biologics Consulting is pleased to welcome a new member to its Nonclinical Team, Dr. Emily Noonan-Place, Ph.D., MPH.    Emily joins Biologics Consulting after 9 years at FDA (CDER), Office of Oncologic Diseases and has extensive experience with small molecules, biologics (mAbs, ADCs, bi-specifics), oligonucleotide…

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January 28, 2022  •  Blog

The Right CMC Consultant Can Save You Time and Money

You are developing a new pharmaceutical product and think you would benefit from the services of a consultant with expertise in the Chemistry, Manufacturing, and Controls (CMC) requirements of global pharmaceutical regulatory bodies, but you also need to make the most of your CMC budget. Although CMC…

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December 14, 2021  •  Whitepaper

Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment

The Stability Community of the American Association of Pharmaceutical Scientists (AAPS) held a virtual workshop on "Vaccine Stability Considerations to Enable Rapid Development and Deployment", on March 24-25, 2021. The workshop included distinguished speakers and panelists from across the industry,…

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November 8, 2021  •  Blog

FDA Resumes Medical Device Inspections – What now?

FDA Resumes Medical Device Inspections It is much more likely that you noticed changes to what the FDA has been doing during the COVID-19 pandemic rather than changes to what it has not been doing.  One example of what they have been doing is the review and issuance of Emergency Use Authorizations. …

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