Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products
Closed Solicitation Posted
This opportunity was awarded. See its 5 award notices in the notice history.
- Solicitation number
- 75N95023R00037
- Agency
-
National Institute on Drug Abuse
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325412 Pharmaceutical Preparation Manufacturing
- Place of performance
- United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Therapeutic Development Branch (TDB) at the National Center for Advancing Translational Sciences (NCATS) is seeking a contractor to provide Chemistry, Manufacturing, and Control (CMC) services for Drug Products. The contractor will be responsible for the design, development, manufacture, and release of Drug Products, including ancillary products and materials to support clinical trials or CMC activities, and all activities preliminary to manufacturing in accordance with current Good Manufacturing Practice (cGMP). The contractor will also handle storage, shipping, testing, and preparation of documents to support regulatory submissions, and may need to work with a variety of product formats, including small molecules, biological molecules, vectors for gene therapy, nanoparticles, and devices or combination products.
Services and products to be provided:
- Design, development, manufacture, and release of Drug Products.
- Production of ancillary products and materials to support clinical trials or CMC activities.
- Activities preliminary to manufacturing in accordance with current Good Manufacturing Practice (cGMP).
- Storage, shipping, testing, and preparation of documents to support regulatory submissions.
- Handling of various product formats, including small molecules, biological molecules, vectors for gene therapy, nanoparticles, and devices or combination products.
Notice text
The Therapeutic Development Branch (TDB) within the Division of Preclinical Innovation (DPI) at the National Center for Advancing Translational Sciences (NCATS) conducts translational research in the area of human therapeutics development.
The scope of this contract is for Chemistry, Manufacturing, and Control (CMC) services for Drug Products. The objective of these support services is to ensure receipt of formulated Drug Product (DP) of sufficient quality and quantity to support preclinical, IND-enabling and clinical studies.
The Contractor shall provide support for a broad range of preclinical services required for the design, development, manufacture, and release of DP, and release of DP as Clinical Trial Material (CTM), including precursors, preliminary states, Reference Standards (RS) and all required testing. Ancillary products (e.g., placebos, diluents, adjuvants, master cell banks, testing standards, reference materials) and other materials manufactured or purchased to support clinical trials or CMC activities may also be required. All activities preliminary to manufacturing in accordance with current Good Manufacturing Practice (cGMP) may be required (e.g., development or engineering lots, formulation studies), even without an associated cGMP manufacturing task. All activities required to maintain material in a usable state, including storage, shipping, testing (in process, release, stability, and quality actions), and preparation of documents to support regulatory submissions may also be required.
Product formats may include small molecules, short oligomeric compounds, biological (large) molecules, quaternary molecular assemblies (homogenous or heterogenous), vectors for gene therapy, nanoparticles, and any of the above modified genetically, biologically, or chemically. Novel formats identified after this draft might also be needed. Formats could also include Devices or Combination Products.
The breadth of this Statement of Work (SOW) includes capabilities to support a range of activities differing in size, complexity, and duration.
All applicable attachments in connection with this solicitation are available for download.
Files
Notice history
| Notice | Type | Posted |
|---|---|---|
| Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products | Pre-Solicitation | |
| Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products | Pre-Solicitation | |
| Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products | Award Notice | |
| Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products | Award Notice | |
| Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products | Award Notice | |
| This notice | Solicitation | |
| Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products | Pre-Solicitation |
7 of 9 notices listed here. See the rest on GovTribe.
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| Opportunity | Agency | Set-aside | Responses due |
|---|---|---|---|
| Synthesis and Distribution of Drugs of Abuse and Related Compounds | National Institute on Drug Abuse | No set-aside |
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