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 (NIH), is conducting 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 market research aims to inform future acquisition strategies, including potential set-asides. Responses are due March 4, 2026, at 9:00 AM Eastern Time.
Scope of Work
The selected contractor will be responsible for a comprehensive range of services related to pharmaceutical development and manufacturing, including:
- Pre-formulation studies on drug substances.
- Development and manufacturing of dosage forms/drug products and placebos.
- Development and validation of analytical methods.
- Establishing specifications for dosage forms/drug products.
- Determining stability of finished dosage forms/drug products.
- Maintaining storage facilities for drug substances and finished products, including controlled substances.
- Shipping drug substances and dosage forms/drug products to designated NIDA sites.
- Generating reports and data necessary for NIDA's Investigational New Drug (IND), New Drug Application (NDA), and/or Drug Master File (DMF) preparation.
Contract & Timeline
- Opportunity Type: Sources Sought Notice (AN11 - Health R&D Services; Basic Research)
- Anticipated Contract Type: Five (5) year Indefinite Delivery/Indefinite Quantity (IDIQ) Task Order (TO) type contract.
- Set-Aside: NIDA is particularly interested in small business sources for this effort.
- Response Due: March 4, 2026, 9:00 AM Eastern Time
- Published: February 17, 2026
Submission & Evaluation
Interested companies must submit a capability statement demonstrating their ability to meet the project requirements. Statements should include:
- Total number of employees.
- Professional qualifications of key personnel.
- Any relevant GSA Schedule or Government-Wide Acquisition Contracts (GWACs).
- Company Name, Unique Entity ID (UEI), Physical Address, and Point of Contact information. Statements must be in Microsoft Word or Adobe PDF format, using 11- or 12-point font, 8-1/2" x 11" paper, 1" margins, and single or double spacing. The response is limited to ten (10) pages, excluding cover page, executive summary, or references. Submissions should be sent electronically to scott.duernberger@nih.gov.
Eligibility / Set-Aside
Respondents must identify their business type (e.g., small business, HUBZone, service-disabled veteran-owned, 8(a), veteran-owned, woman-owned, or small disadvantaged business) and size classification relative to the applicable NAICS code. Organizations not considered small businesses under the relevant NAICS code should not respond. If domestic sources are available and capable, evaluation preferences may be applied in accordance with FAR 25.
Additional Notes
This is a market research notice, not a solicitation for proposals. The Government is not obligated to acknowledge receipt of responses or provide feedback. Responses will not be considered adequate for a future solicitation. Do not include proprietary, classified, confidential, or sensitive information.