About The Williamsburg Group

The Williamsburg Group provides expert pharmaceutical consulting services including CGMP compliance, quality systems, aseptic processing and sterilization, sterilizing filtration, design review, due diligence, and regulatory liaison. Our clients appreciate the practical approach we use to effectively and efficiently solve their problems.

Russell E. Madsen


Mr. Madsen is President of The Williamsburg Group, LLC, and has led the organization since its founding in 2003. He has over forty-five years of experience in the pharmaceutical industry.

Prior to forming The Williamsburg Group, he served the Parenteral Drug Association as Acting President and was Senior VP Science and Technology, responsible for the overall scientific, technical and regulatory affairs activities of the association. These responsibilities included publishing internationally respected technical reports, writing consensus positions on proposed FDA and international regulations and guidance documents, developing the scientific content of PDA's meetings and forums, working with associations such as PhRMA, CHPA, AdvaMed, AAMI, GPIA, A3P and R3-Nordic to coordinate and harmonize technical activities, and involving FDA and other organizations {e.g., USP, EMA, ISO, PIC/S) in PDA technical committees.

Before joining PDA, he was employed by Bristol-Myers Squibb Company as Director, Technical Services, providing technical and general consulting services to Bristol-Myers Squibb pharmaceutical, medical device, nutritional, and cosmetic operations, worldwide. He was also employed by Sterling Drug, Inc., as an analytical chemist and in laboratory management.

Madsen holds a B.S. from St. Lawrence University and a M.S. in Chemistry from Rensselaer Polytechnic Institute. He is Vice-chairman of ASTM E55 on Manufacture of Pharmaceutical and Biopharmaceutical Products, is a member of the USP Microbiology Expert Committee and Chairman of the USP Visual Inspection of Parenterals Expert Panel, and is a member of Pharmaceutical Technology's Editorial Advisory Board. He is an honorary member of PDA.