Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products
ID: PS75N95025R00005Type: Presolicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NCATSBETHESDA, MD, 20892, USA

NAICS

Pharmaceutical Preparation Manufacturing (325412)

PSC

HEALTH R&D SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH (AN12)

Original Source

https://sam.gov/opp/b8041bbe9d754e5ba93ad4300905c0fe/view
Timeline
    Description

    The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking proposals for Chemistry, Manufacturing, and Controls (CMC) services to support the development of drug products. The primary objective of this procurement is to ensure the provision of high-quality formulated drug products necessary for preclinical and clinical studies, adhering to current Good Manufacturing Practice (cGMP) regulations. This contract is crucial for advancing human therapeutics by facilitating the movement of drug candidates through the preclinical development process until the submission of Investigational New Drug (IND) applications. The Request for Proposals (RFP) is expected to be released on or about December 2, 2024, with contract awards anticipated in the third quarter of FY2025. Interested parties can contact Michelle Cecilia at michelle.cecilia@nih.gov or Valerie Whipple at valerie.whipple@nih.gov for further information.

    Point(s) of Contact
    Michelle Cecilia
    (301) 827-7199
    michelle.cecilia@nih.gov
    Valerie Whipple
    13018275218
    valerie.whipple@nih.gov
    Files
    Title
    Posted
    3 - Ramp-On - TRND 3 - SOW - CMC DP 8_23_24.pdf
    The National Institutes of Health (NIH) is soliciting Chemistry, Manufacturing, and Controls (CMC) services for the development of drug products through a Statement of Work (SOW) under an indefinite-delivery, indefinite-quantity (IDIQ) contract. The Therapeutic Development Branch (TDB) within the National Center for Advancing Translational Sciences (NCATS) aims to advance human therapeutics by moving drug candidates through the preclinical development process until reaching Investigational New Drug (IND) application submission. The contractor will ensure the provision of high-quality and quantity formulated drug products for preclinical and clinical studies while adhering to current Good Manufacturing Practice (cGMP) regulations. The contract encompasses a wide range of responsibilities, including project management, communication with stakeholders, and quality management, to maintain compliance with regulatory standards. Key activities include formulation development, analytical method validation, and manufacturing of various drug products, including small molecules, peptides, and biologics. The document emphasizes the necessity for collaboration, quality assurance, and thorough documentation throughout every phase of drug development to successfully execute the contract’s objectives and support innovation in the therapeutic space.
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