Regulatory Consulting
Our regulatory consultant is a physician who has worked at FDA/CBER and HRSA. She is uniquely experienced in working closely with stakeholders throughout the tissue, organ, and cell communities world-wide. She has expertise in program development and administration, regulatory analysis, research and document preparation for use in regulatory submissions.
FDA Regulatory Consulting
Donor screening and testing
HCT/P regulations
Applications for HCT/Ps, donor testing assays, combination products involving HCT/Ps
Provide advice on combination product regulatory pathway
Medical Director Services
HCT/P establishments
OPO Administrative Medical Director
Strategy Consulting
Organ, eye and tissue establishment regulatory and policy issues
Marketing and government relations for products in regenerative medicine, organ transplantation, tissue and eye transplantation, xenotransplantation
Melissa Greenwald, MD
Dr. Melissa Greenwald is a 1997 graduate of the Uniformed Services University School of Medicine. She trained in internal medicine at Bethesda Naval Hospital, and was board certified in 2000 and 2010. Dr. Greenwald worked at FDA in the Center for Biologics between 2000-2014 when she departed as the Chief, Human Tissue and Reproduction Branch, Division of Human Tissues, Office of Cellular, Tissue and Gene Therapies. At FDA, she was involved in finalizing the 1271 regulations, was the champion for all guidance documents and policy related to screening tissue and cell donors, and was the lead scientific reviewer for all infectious disease donor screening assays with an indication for use with testing organ, tissue and cell donors. Dr. Greenwald worked at the Health Resources and Services Administration, Division of Transplantation between 2014 and 2018, where she served as the Director of the Division of Transplantation between October 2015 until retiring from Active Duty in March 2018. Throughout her career, Dr. Greenwald has worked closely with all stakeholders throughout the tissue, organ, and cell communities worldwide. She has expertise in national program development and administration, policy development, and regulatory-related research and document preparation. MA Greenwald Consulting provides consultative services in all areas of tissue and organ transplantation, including regulatory consultation on multiple aspects of FDA tissue and biologics regulations, physician of record service, and as a medical/scientific advisor.