GMP Synthesis of Bulk Drug Testing

The National Institute on Drug Abuse (NIDA) seeks capability statements from Small Businesses (e.g., 8(a), veteran-owned, service-disabled veteran-owned, HUBZone, small disadvantaged, and woman-owned small businesses). Offerors must provide the Good Manufacturing Practices (GMP) synthesis of bulk drug substances to the medications development program of NIDA for toxicological and clinical trials. Offerors must demonstrate the ability to manufacture bulk drug substances under both GMP following relevant Food and Drug Administration (FDA) guidance and regulations (e.g. Code of Federal Regulations Title 21) and non-GMP. Offerors must indicate experience in producing GMP and non-GMP drug substances in batch sizes of at least one kilogram or larger, appropriately store GMP and non-GMP materials on site, and maintain a facility in good standing with the FDA. Offerors must have onsite access to state-of-the-art equipment for analytical testing (high-performance liquid chromatography (HPLC), gas chromatography-mass spectrometry (GC-MS), liquid chromatography-mass spectrometry (LC-MS), isotope ratio (IR), circular dichroism (CD) and nuclear magnetic resonance (NMR)). Offerors must show experience in preparing reports acceptable in format and substance for adaptation into a Chemistry, Manufacturing and Control (CMC) section for each drug substance for submission to the FDA in support of Investigational New Drug (IND) and New Drug Application (NDA) applications. To handle substances or starting materials under the Controlled Substance Act of 1970, offerors must possess Drug Enforcement Administration (DEA) Research and Manufacturing Registrations for Schedules II to V controlled substances and demonstrate the capability to obtain DEA Research and Manufacturing Registrations for Schedule I controlled substances. Please see the attachment for more details.