CCSA is proud to announce we have been selected by the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH) of the U.S. Department of Health and Human Services (HHS) to provide comprehensive regulatory services to NCATS including pre-IND and IND support. CCSA’s pre-IND meeting support will include the preparation of briefing packages, regulatory expertise during the meeting and the preparation of meeting minutes and formulating responses to questions posed by the FDA. CCSA will also prepare all the necessary IND modules for NCATS and carry out IND submissions. Subsequent to IND submission, CCSA will provide IND maintenance for the NCATS program, updating required regulatory documents, including preparation of annual reports and providing other ongoing support for NCATS to advance their drug development pipeline.
