Pharmaceutical Products for CDER Research Studies - IDIQ
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 U.S. Food and Drug Administration (FDA) is conducting market research for a future five-year Indefinite Delivery, Indefinite Quantity (IDIQ) contract to procure pharmaceutical products for the Center for Drug Evaluation and Research (CDER) research studies. This Sources Sought notice aims to identify qualified manufacturers and suppliers of brand name and generic pharmaceuticals, including small molecule, peptide therapeutics, drug-device combination products, and contrast agents. The FDA is particularly seeking small business sources, though all interested parties are encouraged to respond. Responses are due by March 18, 2026.
Scope of Work
The future IDIQ contract will establish a reliable source for currently marketed pharmaceutical drug products. The contractor will fulfill orders on an as-needed basis, supplying products listed in Attachment 1 (e.g., specific drug names, strengths, sizes, NDC numbers, and estimated unit prices) and potentially other unlisted products. Deliveries will be made to various FDA offices, laboratories, and external research collaborators both domestically and internationally, with specific delivery timelines (e.g., 7 business days for domestic, 14 for international, emergency overnight). The estimated contract value is a minimum of $10,000 and a maximum of $4,000,000 over five years.
Contract & Timeline
- Type: Sources Sought / Market Research (for a future IDIQ)
- NAICS: 325412 - Pharmaceutical Preparation Manufacturing (Size Standard: 1300 employees)
- Set-Aside: Market research to determine potential small business set-aside; open to all businesses.
- Response Due: March 18, 2026, 1:00 PM CT
- Published: March 5, 2026
- Anticipated IDIQ Period of Performance: August 1, 2026 – July 31, 2031 (five one-year ordering periods)
Submission Requirements
Interested parties must submit capability statements including:
- Business name, SAM UEI, address, website, size status (SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), and point of contact information.
- Descriptive literature demonstrating capability to meet requirements, including technical specifications for items in Attachment 1.
- Three years of past performance for similar products/services.
- GSA Schedule contract information (if applicable).
- Best in Class (BIC) contract information (if applicable).
- Information on Section 508 accessibility compliance (e.g., ACR).
- Feedback on restrictive specifications.
- Subcontracting opportunities for small businesses (if a large business).
- Standard commercial warranty and payment terms.
- Place of product manufacture for Buy American Act considerations.
- Informational pricing.
Additional Notes
This is for market research only and does not constitute a request for proposal or solicitation. The government will use responses to determine future acquisition strategy (e.g., small business set-aside, full and open competition, sole-source). Responses will not be acknowledged, and no feedback will be provided. Do not include proprietary, classified, or sensitive information.