Office of Regulated Activities Support Services

The Defense Health Agency Research and Development (DHA R&D) Medical Research and Development Command is seeking a Contract Research Organization (CRO) to provide comprehensive regulatory, clinical, administrative, and technical support services for the Office of Regulated Activities (ORA). The scope of work encompasses medical product development support for drugs, biologics, medical devices, and combination products, including regulatory consultation, oversight, project management, clinical trial support, data management, pharmacovigilance, quality assurance, and medical writing services. This is a Request for Information (RFI) and Sources Sought notice for market research purposes only and does not constitute an actual solicitation. Interested companies must submit a 10-page Capability Statement detailing their experience, expertise, novel ideas, previous deliverables, ability to obtain security clearance, subcontracting approach, and specific capabilities that match the outlined work requirements. The submission deadline is October 8, 2025, at 3:00 PM Eastern Time, with responses to be sent to ronald.s.sanford2.civ@health.mil.

This opportunity does not specify any set-aside designation and appears to be open to all qualified contractors. No incumbent contractors or current service providers are identified in the notice. While specific contract values or budget ranges are not disclosed, the government estimates that approximately 37 Full Time Equivalent (FTE) support personnel will be needed to fulfill the requirements, indicating this could be a substantial contract opportunity. The timeline for actual procurement has not been established, as this is preliminary market research with no guarantee that a future procurement will result from this RFI. The notice emphasizes that this is strictly for information gathering purposes to assess industry capabilities and capacity in the medical product development support sector.