Combination Product Testing and CRO-Like Operations

The contract seeks a subcontractor to conduct CRO-like testing on combination products, such as drug-device systems, under regulated conditions to generate data supporting regulatory submissions. The work must adhere to applicable quality and compliance standards to ensure the validity and acceptability of results by regulatory bodies, with a focus on the unique challenges posed by integrated therapeutic products. Performance is expected to include study design, execution, documentation, and reporting that align with industry best practices for combination product evaluation. This opportunity is classified under NAICS code 541690, indicating it involves other scientific and technical consulting services, and is issued by the Defense Advanced Research Projects Agency under the Department of Defense. While no set-aside provisions are specified, the contract is open to eligible subcontractors who can demonstrate capability in regulated testing environments. Responses are due by July 29, 2026, and the work will be performed without a specified location, allowing flexibility as long as regulatory and operational requirements are met. Contractors must be prepared to support defense-related medical innovation through rigorous, compliance-driven testing protocols.