Christina Sanchez Miller, MPHPresident/CEO Christina has over 20 years of management, biologics, quality assurance and research experience in the medical field. She is a published author in scientific books, papers and has presented at several international conferences. Christina has developed medical applications in the biologics field. She has assisted foreign health departments in writing legislation…

VP of Global Business Development

Dallas L. Thomas, RAC, MHA, MPA, SSYBRegulatory Expert Dallas L. Thomas, RAC, MHA, MPA has 14 years’ experience in the medical device industry in the areas of regulatory affairs, quality management systems, compliance, auditing, and clinical evaluation. Dallas works on activities associated with FDA submissions, particularly 510(k), Emergency Use Authorizations, FDA Enforcement Policies, FDA Establishment Registration,…

VP of Global Business Development

Donald Klein, PhDRegulatory Expert Dr. Klein is a regulatory, scientific CMC Expert with 23 years (1995 – 2017) of experience as a Senior Review Chemist of new drugs in CDER/FDA where he received upon retirement the FDA Distinguished Career Service Award (2017) from the FDA Commissioner. While at the FDA, Don significantly contributed to developing…

VP of Global Business Development

Bill Spanogle, PhD, MS Sr Director of Product & Process Development Bill is a highly accomplished, adaptable C-Level Advisor and hands-on leader in the full spectrum of Regulated Life Sciences Product & Process Development, RA/QA, EU-MDR/IVDR, QbD, and CSV-GAMP-Part11. Bill has  successfully characterized and taken scores of medical devices, Biotech, Pharma, and Combo Products, Designs, Materials, & Processes…

VP of Global Business Development

Nadine Bewry, PhD, MS, MPH Director of Regulatory Affairs Nadine is a former FDA Regulatory Scientist and Project Manager. She has over 10 years of experience with FDA regulated products, including drugs, biologicals, combination products, and food ingredients. She is a Regulatory and Medical Science Professional with clinical research and pharmaceutical experience. Additionally, Nadine’s areas…

VP of Global Business Development

Michael Miller, MBA VP of Global Business Development For more than 20 years, Michael has developed innovative solutions for customers across the globe. He has negotiated agreements with governmental authorities in the Middle East, Asia, Africa, Europe and the Caribbean to insure his clients are able to transact business in the US with seamless integration.…