ATMP Clinical Development Regulatory Strategy in 2023 – Playbook 8 ATMP Clinical Development Regulatory Strategy in 2023 – Playbook 8 Advanced Therapy Medicinal Products (ATMPs) present unique challenges and opportunities in the realm of regulatory affairs. As more organizations navigate the complexities of developing cell and gene therapies, a comprehensive understanding of the regulatory landscape becomes essential. This article serves as a detailed step-by-step guide for professionals engaged in ATMP regulatory consulting, focusing on the key processes from preclinical development to post-approval commitments in the United States. This detailed playbook highlights the necessary actions, documentation expectations, and regulatory requirements applicable…