GMP Synthesis of Bulk Drug Testing

The National Institute on Drug Abuse intends to solicit proposals for a five-year indefinite delivery, indefinite quantity contract to manufacture bulk drug substances under good manufacturing practices. Offerors must be certified under NAICS Code 541715 for research and development in physical, engineering and life sciences to produce bulk drug materials to support NIDA's preclinical safety testing and clinical trials. Offerors must demonstrate the ability to manufacture substances under both GMP and non-GMP standards and store them onsite, with experience in producing GMP and non-GMP substances and preparing reports for regulatory submissions. Facilities must be in good standing with the FDA and have necessary DEA registrations to handle controlled substances from Schedules I through V. The solicitation will be posted on March 20, 2024 on SAM.gov and NIDA's website, with responses due approximately 45 days later.

There is no set-aside designation. The primary NAICS code is 541715 and PSC code R408. The award will include both cost reimbursement and fixed price task orders over the five year contract period to support production of bulk drug substances as needed for NIDA's preclinical and clinical programs.