Prototype Development Service

The government authority located in Fort Detrick, MD requires a vendor to provide a prototype development service. The buyer expects the selected vendor to prepare human use protocols and submit them to relevant human use regulatory agencies. Additionally, the vendor must develop and execute a regulatory strategy for the wound infection barrier combination to achieve approval and clearance for an adult indication. The scope of work also requires the vendor to complete necessary optimization, processing development, manufacturing validation, and manufacturing stability testing. The buyer limits eligibility strictly to onshore USA organizations only, and the vendor will perform all work offsite. Regarding the budget, the buyer is actively looking for proposals. The provided text does not contain any key dates or specific evaluation criteria.