Richard Tharin, MS, RAC

Biography

Richard Tharin, MS, RAC, has more than 20 years in Biotech, Medical Device and Pharma regulatory affairs and as much time as a Cell Biologist, Biochemist and Molecular Biologist. He is the founder and CEO of Cerneos Group, LLC, an end-to-end life science consulting firm. He has managed programs in vaccine, cell biology and diagnostic product development from early stage to commercialization. As a medical device specialist, he has developed and managed validation, commissioning and quality systems for a wide variety of medical devices, diagnostics and combination products.

His validation experience includes the development of equipment, facilities and systems validation programming for medical devices and combination products. He has been responsible for development of Validation Master Plans (VMP), revalidation and retrospective validation programs for biotech, pharma and medical device facilities and equipment. He has designed validation plans and documentation programs for Fortune 100 companies and startup firms.

Mr. Tharin’s experience includes more than 100 successful regulatory submissions, registrations and positive interactions with the FDA, Health Canada, EMEA, National Health Service and other international health authorities. His specialties include infectious diseases, oncology, cardiology, diagnostics, Women’s Health and Rehabilitation medicine. His client base has included large firms such as Red Cross Tissue Services, NIAID/NIH, Terumo Medical, Kimberly Clark, US Navy and a host of startup firms. In addition to his duties as CEO, he acts as a project manager, professional trainer and business developer. He enjoys working with all levels of management to deliver personalized service.