News & Insights
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…
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…
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…
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…
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…
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…
Biologics Consulting Expands Pharmacology-Toxicology Expertise; Adds Two Senior Consultants To Growing Team
Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, announced today the expansion of its Pharmacology-Toxicology team with the addition of two new senior consultants with more than two decades of combined experience…
Biologics Consulting Assists BriaCell Therapeutics In Gaining FDA Clearance To Initiate A Phase I/IIa Clinical Trial Of BriaVax™
Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, announced today that its Chemistry, Manufacturing, and Controls (CMC) Specialty Group advised BriaCell Therapeutics Corp. (TSXV: BCT) (OCTCQB: BCTXF), a clinical-stage…
IDRI Expands Board of Directors with Former FDA Leader Norman Baylor
IDRI (Infectious Disease Research Institute) is expanding its Board of Directors, comprised of international leaders in industry and academia, with the recent addition of Norman Baylor, Ph.D., who has extensive experience in the field of vaccines and vaccine-related products, including 20 years with…
Biologics Consulting Expands Footprint, Opens New Office in Maryland’s Technology Corridor
Biologics Consulting, a full-service regulatory and product development consulting firm focused on the life sciences industry, announced today that it is opening a new office in the center of Maryland's Technology Corridor and Life Sciences Hub. The new office is located in Rockville, Maryland and will…