Former FDA Reviewer and Investigator, Division of Manufacturing and Product Quality, CBER, Joins NDA Partners as Expert Consultant

Share Article

NDA Partners President Earle Martin announced today that John Godshalk, MSE, MBA, a former Reviewer and Investigator in the FDA Division of Manufacturing and Product Quality in the Center for Biologics Evaluation and Research (CBER), has joined the firm as an Expert Consultant. Mr. Godshalk is an expert in CMC, quality systems, product development, manufacturing, and cGMP for biologics.

News Image
Mr. Godshalk’s FDA and industry experience and expertise in CMC, quality, product development, manufacturing, and cGMP make him a valuable resource to our clients developing biologics, including cell and gene therapies, vaccines, and biologic devices.

NDA Partners President Earle Martin announced today that John Godshalk, MSE, MBA, a former Reviewer and Investigator in the FDA Division of Manufacturing and Product Quality in CBER, has joined the firm as an Expert Consultant. As an FDA Reviewer, he was responsible for reviewing CMC sections of BLA submissions, leading pre-approval inspections for new biologics, device, and biotechnology products, conducting meetings with industry, and developing regulatory strategies. He is an expert in CMC, quality, and facility issues for cell and gene therapies and has experience with biologics, vaccines, drugs, drug/device combinations, biologic devices, and in vitro diagnostics.

In addition to his FDA experience, Mr. Godshalk has also consulted with small to large biopharma companies on CMC, quality strategy, quality assurance, product development and manufacturing, GMP systems for the US and EU, and auditing and training. Early in his career, he was a Research Engineer at Westvaco Corp. and Pilot Plant Manager at Energy BioSystems Corp.

According to Dr. Ellen Feigal, Manager of NDA Partners’ biologics practice, “We are pleased to welcome Mr. Godshalk to NDA Partners as an Expert Consultant. His FDA and industry experience and expertise in CMC, quality, product development, manufacturing, and cGMP, make him a valuable resource to our clients developing biologics, including cell and gene therapies, vaccines, and biologic devices.”

Mr. Godshalk earned his master’s degree in chemical and biochemical engineering from Johns Hopkins University and MBA in marketing and finance from the University of Maryland, College Park and the Merrick School, University of Baltimore. He received his bachelor’s degree in chemical engineering from North Carolina State University.

About NDA Partners
NDA Partners, a part of The Planet Group, is a life sciences management consulting and contract development organization (CDO) focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and contract management of client product development programs.

Contact
Earle Martin, President
Office: 540-738-2550
MartinEarle@ndapartners.com

Share article on social media or email:

View article via:

Pdf Print

Contact Author

Earle Martin
NDA Partners LLC

Visit website