How to bid on Generic Drug Pathway Curriculum for Health and Human Services

What the FDA is buying and why it matters

The U.S. Food and Drug Administration (FDA) is seeking a professional certification program. This program will train regulatory staff, reviewers, and policymakers from low- and middle-income countries on generic drug regulation, ANDA submissions, and regulatory reliance. The program must issue IACET Continuing Education Units (CEUs).

The FDA's Office of Global Policy and Strategy (OGPS) aims to strengthen global regulatory systems. This initiative helps enhance the capacity of foreign regulatory partners, supporting global public health.

Key dates and what happens at the deadline

This notice was published on August 05, 2026. The deadline for responses is August 20, 2026, at 4:00 PM ET. This is a Request for Information (RFI) and not a request for competitive proposals. The FDA intends to award a sole-source, firm-fixed-price order to DIA Inc. for this requirement.

Who this opportunity suits

This opportunity is specifically for firms with deep subject matter expertise in generic drug regulation aligned with FDA practices, international regulatory harmonization, and regulatory capacity building for low- and middle-income country regulatory authorities. The contractor must have established active relationships with foreign National Regulatory Authorities (NRAs) to support program development and delivery. The North American Industry Classification System (NAICS) code is 611430 - Professional and Management Development Training.

How to access and respond to this notice

To view the original source of this opportunity, click the provided link. If the first click takes you to the portal's homepage, click the link again to go directly to the bid. You may need a free account to view documents, though this is not always required.

This notice is not a request for competitive proposals. The FDA has determined that soliciting from a single source, DIA Inc., is appropriate due to unique capability, immediate availability, highly specialized services requiring institutional knowledge, and time-sensitive mission requirements.

Practical tips for preparing a competitive response

Even though this is a sole-source notice, understanding the agency's needs is valuable for future opportunities. Pay close attention to the specific requirements for the professional certification program, including the need for IACET CEUs and the focus on generic drug regulation and regulatory reliance.

For similar future solicitations, highlight your firm's unique capabilities and specialized expertise. Emphasize any institutional knowledge or established relationships with relevant international bodies that demonstrate your ability to meet time-sensitive mission requirements and deliver highly specialized services.