Development and Manufacture of Pharmaceutical Dosage Forms for Treatment of Substance Abuse Disorders
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The National Institute on Drug Abuse (NIDA), under the National Institutes of Health, is conducting market research through a Sources Sought Notice to identify qualified small businesses capable of developing and manufacturing pharmaceutical dosage forms for the treatment of substance abuse disorders. This effort aims to inform NIDA's acquisition strategy, including potential set-asides, for a future Indefinite Delivery, Indefinite Quantity (IDIQ) contract. Capability statements are due March 4, 2026, at 9:00 AM ET.
Scope of Work
NIDA is seeking capabilities for comprehensive pharmaceutical development and manufacturing, including:
- Pre-formulation and formulation studies of drug substances.
- Manufacturing and packaging of finished dosage forms and placebos.
- Analytical method development, validation, and establishment of specifications.
- Conducting stability studies.
- Maintaining storage facilities for drug substances and finished products, including controlled substances.
- Shipping drug substances and dosage forms to designated NIDA sites.
- Generating reports and data for Investigational New Drug (IND), New Drug Application (NDA), and Drug Master File (DMF) preparations.
- Ensuring compliance with FDA's current Good Manufacturing Practice (cGMP) and Good Laboratory Practices (GLP), and obtaining appropriate DEA Registrations.
Contract & Timeline
- Type: Sources Sought / Market Research (for an anticipated IDIQ Task Order contract)
- Anticipated Duration: Five (5) years
- Set-Aside: Market research for potential small business set-asides; NIDA is specifically interested in small business sources.
- Response Due: March 4, 2026, 9:00 AM ET
- Published: February 17, 2026
Submission & Evaluation
Interested companies must submit a capability statement addressing their ability to meet the project requirements. Statements should be in Microsoft Word or Adobe PDF, 11-11pt font, 8.5x11 paper, 1" margins, and limited to ten (10) pages (excluding cover page, executive summary, and references). Submissions must include total employees, personnel qualifications, GSA Schedule/GWACs (if applicable), company name, Unique Entity ID, physical address, and points of contact. Responses will be used for market research to determine small business availability and inform the acquisition strategy.
Additional Notes
This notice is for information and market research purposes only and is not a solicitation for proposals. No award will be made as a result of this notice, and the Government will not reimburse costs incurred by respondents. Organizations not considered small businesses under the applicable NAICS code should not respond.