Sources Sought: Analytical Chemistry and Stability Testing of Treatment Drugs for Substance Use Disorders

Event Organizer: National Institutes of Health

Event Website: https://sam.gov/opp/2207f3f130b44d8783a14760ba8444d9/view

Event Overview:

Solicitation #: 75N95023R00057UR

“The National Institute on Drug Abuse (NIDA) is seeking Capability Statements from Other Than Small Business (OTSB) organizations to provide the Government support for analytical chemistry and stability testing of treatment drugs for substance use disorders.”

“Capable vendors shall demonstrate their ability, experience, and expertise to develop and validate analytical methods, perform quality control tests, prepare reference standards, and perform stability studies of drug substances and products. In addition, capable vendors shall demonstrate their ability, experience, and expertise to provide satisfactory facilities for the storage of drug substances and finished dosage forms. Capable vendors shall demonstrate their ability, experience, and expertise to make a limited number of shipments of drug substances and dosage forms to the sites designated by the NIDA. Capable vendors shall demonstrate their ability, experience, and expertise to manage an up-to-date tracking system to track the status of all drug substances and drug products being studied under this contract. It is also necessary for Capable vendors to demonstrate their ability, experience, and expertise to track all drug products and drug substances in various stages of stability testing.

Capable vendors should demonstrate their ability, experience, and expertise to carry out the tests in compliance with Food and Drug Administration (FDA) current Good Manufacturing Practice regulations (cGMP) and Good Laboratory Practices (GLP). The data and documents prepared must adequately support Drug Master File (DMF), Investigational New Drug (IND) or New Drug Application (NDA) submitted by NIDA or investigators supported by the NIDA to the FDA.”

Due date: 30 June 2023, 4:00 p.m. EDT