Quality Assurance and Regulatory

Tissue engineered products are medicinal products, classified as Advanced Therapy Medicinal Product (ATMP) by European Regulation. Regulatory/QA Department provides support at any stage of ATMP products development, ensuring that appropriate studies and tests are performed, in compliance with the regulatory framework. It assures an early dialogue with Regulatory Authorities to determine the extent of quality, non-clinical and clinical data, due to the specific nature of ATMP, avoiding product marketing delays.