Medical Writing and Regulatory Affairs

The Medical Writing and Regulatory Affairs team at PPD is responsible for the creation and management of crucial documentation required for regulatory submissions and compliance. This team collaborates closely with clinical and safety experts to produce high-quality clinical study reports, safety narratives, and regulatory filings, ensuring that all written materials meet stringent industry standards and support the timely development and approval of life-changing therapies. Their expertise in pharmacovigilance and regulatory requirements helps clients navigate the complexities of the drug development process.