Advertisement
ROCHELLE, Va., Dec. 19, 2018 /PRNewswire-PRWeb/ -- NDA Partners Chairman Carl Peck, MD, announced today that Deb Koeneman, MS, former Scientific Reviewer and Compliance Officer at the FDA Center for Devices and Radiological Health (CDRH), has been appointed a Partner in the firm. Ms. Koeneman has worked with NDA Partners as an Expert Consultant since 2015, and she has more than 25 years of regulatory experience. In addition to her FDA career, she was formerly the Director of Regulatory Affairs at Silverleaf Medical Products (Vomaris Innovations) and Senior Director of Regulatory Affairs and Regulatory Compliance Manager at OrthoLogic Corporation (Capstone Therapeutics).
Ms. Koeneman has been consulting for medical device, pharmaceutical, and combination biologic/device/drug companies for over 12 years. She has extensive experience managing and directing regulatory and quality assurance departments and performing due diligence for early stage new molecular entity peptides, novel medical devices, and combination products. Her areas of expertise include development strategy, pathway to market, regulatory submissions, and compliance. Her career highlights include developing and implementing strategies regarding medical devices, combination products, IDEs, PMAs, INDs, and helping to transform a medical device company into a drug development company.
According to Dr. David Feigal, Manager of NDA Partners' Medical Device Practice, "Ms. Koeneman's expertise in development and regulatory strategy, regulatory submissions, and compliance have been highly valued by our clients, and her leadership as a Partner in the firm will play a critical role as we expand the product development services that we offer to our clients. We are very pleased to welcome her as a Partner in the firm."
Ms. Koeneman earned a BSE in Biomedical Engineering and a MS in Bioengineering from Arizona State University. She currently serves as a guest lecturer on FDA-related regulatory topics at Arizona State University and as an industrial advisory board member at Grand Canyon University.
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 [email protected]
SOURCE NDA Partners, LLC
Advertisement
Ms. Koeneman has been consulting for medical device, pharmaceutical, and combination biologic/device/drug companies for over 12 years. She has extensive experience managing and directing regulatory and quality assurance departments and performing due diligence for early stage new molecular entity peptides, novel medical devices, and combination products. Her areas of expertise include development strategy, pathway to market, regulatory submissions, and compliance. Her career highlights include developing and implementing strategies regarding medical devices, combination products, IDEs, PMAs, INDs, and helping to transform a medical device company into a drug development company.
According to Dr. David Feigal, Manager of NDA Partners' Medical Device Practice, "Ms. Koeneman's expertise in development and regulatory strategy, regulatory submissions, and compliance have been highly valued by our clients, and her leadership as a Partner in the firm will play a critical role as we expand the product development services that we offer to our clients. We are very pleased to welcome her as a Partner in the firm."
Ms. Koeneman earned a BSE in Biomedical Engineering and a MS in Bioengineering from Arizona State University. She currently serves as a guest lecturer on FDA-related regulatory topics at Arizona State University and as an industrial advisory board member at Grand Canyon University.
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 [email protected]
SOURCE NDA Partners, LLC
