Combined Synopsis/SolicitationPosted Dec 20, 2024·Responses due Feb 3, 2025

Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products

National Institutes of Health · NATIONAL INSTITUTES OF HEALTH NIDA

Stage
Open solicitation
NAICS
325412
Value
Not stated
Solicitation
75N95025R00005
Set-aside
None stated
PSC
AN12
Place
Rockville, MD, USA
Contact
Michelle Cecilia (michelle.cecilia@nih.gov)
CSV Email

Capture briefs (a one-page, shareable copy of this page) are part of Pro. The CSV here holds the notice, its timeline and past awards.

Where this opportunity stands

Every notice posted under solicitation 75N95025R00005 in this department, oldest first.

Early notice
None posted
Solicitation
  • Nov 30, 2024
    Combined Synopsis/Solicitation
    Open
  • Dec 20, 2024 · this notice
    Combined Synopsis/Solicitation
  • Jan 14, 2025
    Combined Synopsis/Solicitation
    Open
Award
  • Jul 8, 2026
    Award Notice
    SRI INTERNATIONAL Menlo Park CA 94025 USA · $49.9M
    Open
  • Jul 8, 2026
    Award Notice
    KYMANOX CORP · $49.9M
    Open
  • Jul 8, 2026
    Award Notice
    MURTY PHARMACEUTICALS, INC. · $49.9M
    Open
  • Jul 8, 2026
    Award Notice
    EMINENT SERVICES CORP · $49.9M
    Open

Next steps for this stage

Standard steps for the notice type; not advice about this buyer.

  • Decide bid or no bid before the response deadline.
  • Look at the past winners for likely competitors and teaming partners.
  • Follow the opportunity to hear about amendments and the award.

What the notice says

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 preclinic… (show all)

al 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.

Who won similar work

4 award notices on SAM.gov in the last 24 months. Matched by: Same office (NATIONAL INSTITUTES OF HEALTH NIDA), same NAICS 325412.

WinnerAwardsValueLast
ALCHEM LABORATORIES CORPORATION1– + 1 sharedMay 5, 2026
CURIA GLOBAL INC1– + 1 sharedMay 5, 2026
MRIGLOBAL Kansas City MO 64110 USA1– + 1 sharedMay 5, 2026
SRI INTERNATIONAL Menlo Park CA 94025 USA1– + 1 sharedMay 5, 2026

Value counts single-winner awards. "Shared" awards are multiple-award contracts that list every winner with the same total ceiling; that ceiling is not one company's win, so it is not added in. Revenue next to a ticker is the company's last annual revenue from its 10-K.

Latest awards

Competitive landscape

For the 4 most frequent past winners above. Lobbying is matched by the company's exact name or exact ticker; agencies are as named on the filings.

  • 0 of these past winners lobbied Natl Institutes of Health (NIH) since 2024 (0 filings)
  • 0 of their lobbyists list a past Natl Institutes of Health (NIH) job
  • No corporate PAC money from them to the overseeing committees since 2024
  • 0 foreign-agent (FARA) registrations
See who and the source records with Pro

Policy around it

Bills the past winners named while lobbying this agency's issues, rules from the department, and executive orders that name the agency, last 12 months.

  • 0 bills named on the past winners' lobbying filings
  • 0 rules from the department in the last 12 months
  • 0 executive orders naming the agency in the last 12 months
See who and the source records with Pro

Market

For past winners matched exactly to a listed company. Insider trades are open-market buys and sells (Form 4) in the last 90 days, shown as facts; our own study found insiders do not reliably buy ahead of awards. A sale marked 10b5-1 was made under a trading plan set up in advance.

  • 0 of the past winners are listed companies
  • 0 insider buys and 0 insider sells at them in the last 90 days
See who and the source records with Pro

Sources: SAM.gov notices and award notices; Senate LDA lobbying filings; FEC filings; FARA; Federal Register; congress.gov; SEC Form 4. Every row above links to its record.

Companies are matched to tickers by exact name only. A company we could not match shows no market rows; that is a miss, not a finding.