HI-6 Dimethanesulfonate (DMS) and Atropine Sulfate Reconstitution Autoinjector Device (RAD) Feasibility Assessment

The Department of National Defence, through Canadian Forces Health Services, is seeking a contractor to assess the feasibility of manufacturing HI-6 dimethanesulfonate and atropine sulfate within a reconstitution autoinjector device, using an existing prototype configured with 500 mg plus or minus 25 percent HI-6 DMS in a dry chamber and 1 mL of atropine at 2 mg/mL in a liquid chamber. The work requires a fully automatic reconstitution process with no manual steps such as mixing, priming, or shaking, and demands a dual-chamber design with a defined reconstitution pathway. The contractor must demonstrate a working prototype that meets these specifications and has received regulatory approval from the FDA, EMA, or Health Canada within the past five years for a military-use autoinjector device. The evaluation is structured around mandatory pass/fail gates covering prototype functionality, device design, and regulatory compliance, with the contract anticipated to be awarded to kaleo, Inc., the pre-identified supplier, unless another qualified party submits a Statement of Capabilities by the deadline of June 16, 2026, that meets all requirements. The scope includes project management, analytical method development, material processing and performance assessments, drug delivery modeling, and sterilization impact evaluation, with deliverables scheduled through mid-2027, including the Analytical Method Summary Report due September 30, 2026, Formulation and Drug Delivery Model Reports due March 31, 2027, and the Sterilization Impact Assessment Report due June 30, 2027. The procurement falls under NAICS code 541715 and is governed by Canada’s Buy Canadian policies only if a competing offer is received, but no set-asides apply. All submissions must be directed to the point of contact, Alan Escobedo Fox, and must include documentation proving compliance with cGMP standards for manufacturing.