325411 – Medicinal and Botanical Manufacturing

325412 – Pharmaceutical Preparation Manufacturing

541690 – Other Scientific and Technical Consulting Services

541712 – Health Research and Development Laboratories or Services

541715 – Research and Development in the Physical, Engineering, and Life Sciences

541720 – Research and Development in the Social Sciences and Humanities

541990 – All Other Professional, Scientific, and Technical Services

U.S. Department of Health & Human Services                                                                                                                   National Institutes of Health (NIH) – The National Center for Advancing Translational Sciences (NCATS)            Title: CRO Support for NCATS Regulatory Affairs Support and Related Services

Type: IDIQ, 2022-06-10 to 2027-06-09

The National Center for Advancing Translational Sciences (NCATS) provides regulatory affairs services that can fully support drug development projects from pre-clinical through clinical phases. Therapies under development can cover a wide range of modalities, such as small molecules and biologics (e.g. antibody, proteins, and cell and gene therapy), and can be at different stages of pre-clinical or clinical development that requires varying levels of support. This may include drugs, medical devices used in drug delivery, or drug-device combinations.