Triazine Drug Manufacturing

The United States Army Medical Research Acquisition Activity (USAMRAA) intends to negotiate on a sole source basis, IAW FAR 6.302-1(a), with the Ricerca Bioisciences, LLC located at 7528 Auburn Road, Concord, Ohio 44077 as the only responsible source that can provide Walter Reed Army Institute of Research to successfully manufacture, label, package, and test a triazine compound in accordance with the manufacturing process, product specification, and analytical test methods specified under each of the following tasks:

Task 1 - Final Quality Agreement/Plan with WRAIR and USAMMDA

Task 2 - Analytical Test Methods

Task 3 - Phase 1 & 2a
Manufacture BDS, formulated into capsules for oral dosing
Manufacture a placebo BDS, formulated into capsules for oral dosing
Shipping & Storage

Task 4 - (Optional) Phase 2b
Manufacture BDS, formulated into capsules for oral dosing
Manufacture a placebo BDS, formulated into capsules for oral dosing
Shipping & Storage

Task 5 - (Optional) Phase 3
Manufacture BDS, formulated into capsules for oral dosing
Manufacture a placebo BDS, formulated into capsules for oral dosing
Shipping & Storage

Task 6 - (Optional)
Formulation of triazine and placebo BDS into an alternate solid oral dosage form.
Shipping & Storage

Task 7 - Technical Data Package (TDP)

Task 8 - eCTD-compliant Module 2 summaries and Module 3 Quality sections