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…

Chief Scientific Officer

Catherine Patterson, PhD Chief Scientific Officer Catherine has over 25 years of experience in directing scientific research. She has extensive experience in scientific research and writing including ongoing regulatory-based and trial-related client projects. Her recent work has focused on human drugs/devices, clinical trials and pharmacovigilance and safety. As an assistant professor, Catherine’s research and teaching…

VP of Epidemiology and Pharmacovigilance

Darren Scheer, MPH, RAC VP of Epidemiology and Pharmacovigilance Darren has more than 20 years of experience with FDA regulated products, including drugs, biologicals, devices and combination products. He has directed and developed various pharmacovigilance and epidemiological assessments. These include over 200 regulatory and development projects requiring FAERS analyses, health claims database assessments, and adverse…

VP of Regulatory Affairs

Mikel Alberdi, MPH, RAC VP of Regulatory Affairs Mikel has vast knowledge and experience with FDA regulations and compliance relating to drugs, biologicals, devices and combination products. He has 15 years of regulatory affairs experience including preparation of FDA submissions (NDA, 505(b)(2) NDA, ANDA, IND), Pre-IND, Pre-NDA, End-of-Phase submissions and facilitation of meetings with FDA.…

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.…