Clarkston Shares Guest Column on Audit Readiness For Cell & Gene Therapy Companies
January 16, 2025 | Clarkston Consulting’s Susan Shockey was recently featured as a guest columnist with Cell and Gene. She shares perspectives on audit readiness for cell and gene therapy companies. Read a short excerpt from the piece below or the full article here.
Audit Readiness For Cell & Gene Therapy Companies
“Cellular and gene therapy (CGT) development areas have been increasingly active, and the approval pipeline for CGT products continues to grow. CGT products, human gene therapy products, and certain devices related to CGT are regulated by the CBER, while the FDA regulates human cells, tissues, and cellular and tissue-based products (HCT/Ps) under Title 21 of the Code of Federal Regulations (CFR), Part 1271. The FDA information page on CGT products provides links to numerous guidance documents and CGT regulatory reference information to help CGT companies understand the regulatory environment specific to CGT. As CGT companies grow and move through the product life cycle, successfully completing a regulatory inspection is a critical step to demonstrating compliance with regulations in order to get approval to start clinical trials or the commercialization of a product.”