Richard C. Tharin, MS, RAC

Richard C. Tharin, MS, RAC

CEO/Founder
Chief Regulatory Consultant

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 has managed programs in vaccine, cell biology and diagnostic product development from early stage to commercialization.

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 specialities 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 start up 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.

Lisa Ganley-Leal, Ph.D.

Lisa Ganley-Leal, Ph.D.

Senior Scientific Consultant, Regulatory Consultant

Lisa Ganley-Leal started her career in academia leading a laboratory at Boston University School of Medicine dissecting unique pathways of chronic inflammation. She worked with biotech and big pharma on developing her patent on allergic diseases, which led her to switch her career to biotech.

She has extensive experience in translational drug development, in particular development of early stage assets from academia to Phase I. In addition, she has demonstrated expertise in solving complex issues in drug and vaccine development. Additional expertise includes human immunology, program and alliance management, scientific intelligence, and global health.

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