Biotechnology - Salt Lake City, Utah, United States
Provides regulatory consulting services for FDA regulated tissue based products, including stem cell therapy, amniotic tissue, tissue allograft products, regenerative medicine, etc. Specializing in the following areas:-Human Cells and Tissue Based Products (HCT/P): FDA tissue establishment registration, FDA communication, quality program implementation, maintenance, auditing, laboratory, processing / manufacturing establishment, product and process validation, assist organizations in the development of tissue activities including: recovery, storage, processing, packaging, labeling and distribution.