Regulatory Haven, LLC

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.