Former SVP of Operations, Regulatory Affairs, and Quality Systems, HTG Molecular Diagnostics, Joins NDA Partners as Expert Consultant


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Mr. Rua’s expertise in quality and regulatory programs and leadership experience across all areas of the medical diagnostics business, in addition to his active engagement with the in vitro diagnostics regulatory community, make him a valuable resource to clients developing diagnostics products.

NDA Partners President Earle Martin announced today that Sam Rua, a regulatory affairs and quality assurance management executive with more than 24 years of experience in vitro diagnostics product development, has joined the firm as an Expert Consultant. Throughout his career, Mr. Rua has successfully established and maintained effective quality and regulatory programs, provided leadership across all areas of the medical diagnostics business, and serves as an active member of the IVD regulatory community, including being on the Association of Medical Diagnostics Manufacturers (AMDM) Board of Directors since 2010.

Prior to joining NDA Partners, Mr. Rua was Senior Vice President of Operations, Regulatory Affairs, and Quality Systems, and Vice President of Regulatory Affairs and Quality Systems at HTG Molecular Diagnostics. He also served as Senior Vice President of Global Regulatory, Clinical, and Government Affairs at Beckman Coulter and in Director positions in regulatory affairs at Roche Tissue Diagnostics, Third Wave Technologies, and Ventana Medical Systems.

According to Dr. Alberto Gutierrez, Manager of NDA Partners’ diagnostics development practice, “Mr. Rua’s expertise in quality and regulatory programs and leadership experience across all areas of the medical diagnostics business, in addition to his active engagement with the in vitro diagnostics regulatory community, make him a valuable resource to clients developing diagnostics products. We are pleased to welcome him to NDA Partners.”

Mr. Rua received his bachelor’s degree in microbiology and chemistry from the University of Arizona.

About NDA Partners

NDA Partners, a ProPharma Group® company, is a life sciences management consulting and contract development organization focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced 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, product development program design and management, expert consulting, functional teams, project-based solutions, and clinical trial design and management.

Contact

Earle Martin, President

Office: 540-738-2550

MartinEarle@ndapartners.com

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