Regulatory Affairs

FHI ensures research quality by complying with national and international regulations and by developing and implementing strategies to adhere to good clinical practice (GCP) guidelines and other federal requirements. At the same time, we provide GCP and regulatory compliance training to sites, investigators, and institutional review boards (IRBs).

Our team prepares and oversees regulatory agency submissions globally. FHI's established relationships with regulatory agencies include those in the Americas, Africa, and Asia. We provide study safety data management and reporting, such as serious adverse events (SAEs), to sponsors. We also manage the procurement, shipping, and tracking of clinical study supplies. Our regulatory expertise includes IRB approval documentation; clinical site, document, and process and system audits; and Title 21 Code of Federal Regulations (21 CFR Part 11) risk assessments.

FHI's trained clinical auditors perform routine site, sponsor, and vendor audits to identify and resolve compliance issues while suggesting strategies for continued improvement. Lessons learned are applied to improve our knowledge and ability to implement quality research in any setting.

For further information, contact services@fhi.org