Development & Manufacture of Pharmaceutical Products for the Treatment of Substance Abuse Disorder

The National Institute on Drug Abuse (NIDA) is soliciting proposals from qualified organizations (NAICS Code 541715) having in-house capability to carry out development of formulations, manufacture, quality control tests, stability studies and distribution of pharmaceutical drug products to be used in the medications development program for treating substance use disorders. Development of medications for the treatment of substance use disorders is a major mission of NIDA. Some of the potential treatment drugs currently being investigated are new chemical entities (e.g., Mitragynine, etc.) and previously approved drug substances. The Government acquires these drugs from private industries, Government contractors/grantees, or independent investigators. This contract is to provide the Government a resource for the development and manufacture of pharmaceutical dosage forms for use in preclinical and clinical studies.

The Contractor shall be responsible for carrying out pre-formulation studies on drug substances, developing and manufacturing dosage forms, developing and validating analytical methods for dosage forms, carrying out stability studies, packaging and delivering of the pharmaceutical products to the sites designated by the NIDA.  In addition, the Contractor shall provide adequate facilities for the storage of bulk drug substances, including controlled substances and their finished dosage forms. The Contractor shall have appropriate DEA Registrations for Schedules II-V Controlled Substances in order to use the controlled substances in research and manufacture of dosage forms under the Controlled Substance Act of 1970. The Contractor must either possess or demonstrate the ability to obtain DEA Registrations for Schedule I Controlled Substances should the research and manufacture of the Schedule I drugs be required under thisindefinite delivery, indefinite quantity (task order) type contract.

The Contractor shall carry out the tasks in compliance with the Food and Drug Administration's (FDA) current Good Manufacturing Practice regulations (cGMP) and Good Laboratory Practices (GLP).  The data and documents prepared should be in a format acceptable to the FDA for inclusion in Drug Master Files (DMF), Investigational New Drugs (IND), or New Drug Applications (NDA) submitted by NIDA or investigators supported by NIDA.