Mark Gonitzke, RPh, MBA, Former FDA Regulatory Reviewer, Office of Generic Drugs, Joins NDA Partners as Expert Consultant

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NDA Partners Chairman Carl Peck, MD, announced today that Mark Gonitzke, RPh, MBA, a Registered Pharmacist with extensive experience in the development of generic drugs and drug/device combination products at FDA in the Center for Drug Evaluation and Research (CDER), has joined the firm as an Expert Consultant.

Mr. Gonitzke’s extensive experience at FDA in the Center for Drug Evaluation and Research in the development of generic drugs and drug/device combination products will provide an excellent resource to our clients.

NDA Partners Chairman Carl Peck, MD, announced today that Mark Gonitzke, RPh, MBA, a Registered Pharmacist with extensive experience in the development of generic drugs and drug/device combination products at FDA in the Center for Drug Evaluation and Research (CDER), has joined the firm as an Expert Consultant.

During his career with FDA, Mr. Gonitzke served as Senior Regulatory Reviewer in the Office of Generic Drugs (OGD), as Regulatory Health Project Officer in the Office of Pharmaceutical Quality (OPQ), as Consumer Safety Officer in the Office of Executive Programs, and as Project Officer in the Division of Data Management and Services. In addition to his FDA career, Mr. Gonitzke served as Emergency Manager in the Division of Emergency and Readiness Operations Response Branch of the US Public Health Service (USPHS) and as an Associate staff member of the USPHS’s Rapid Deployment Force (RDF).

“Mr. Gonitzke’s extensive experience at FDA in the Center for Drug Evaluation and Research in the development of generic drugs and drug/device combination products will provide an excellent resource to our clients,” said Dr. Peck. “We are very pleased to welcome him to NDA Partners.”

Mr. Gonitzke earned a bachelor’s degree in pharmacy from North Dakota State University and an MBA from Chapman University, Anchorage, Alaska.

About NDA Partners
NDA Partners 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 Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; 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, Chief Executive Officer
Office: 540-738-2550
MartinEarle@ndapartners.com

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Earle Martin
NDA Partners LLC
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