Skip to Content
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…

Read More
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…

Read More
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…

Read More
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…

Read More
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…

Read More
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…

Read More
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…

Read More
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…

Read More
January 7, 2020  •  News

Biologics Consulting Expands Management Team with the Addition of Kenneth P. Guito, MBA as Chief Operating Officer

Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, announced today that Kenneth P. Guito, MBA was hired as its Chief Operating Officer (COO) following a 35-year career in the Biotech/Biopharmaceutical Industry. Mr…

Read More
September 12, 2018  •  News

Biologics Consulting Bolsters Medical Device Regulatory Services with the Addition of Four New Consultants

Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, announced today its acquisition of new talent to bolster its Medical Device Specialty Group and support the growing demand for medical device regulatory and product…

Read More