Therapeutic Oligonucleotide Platform Biologics Chemistry, Manufacturing and Controls (CMC) Subject Matter Expert Consultant

This pre-solicitation notice seeks capability statements from small businesses to provide therapeutic oligonucleotide platform biologics chemistry, manufacturing and controls subject matter expert consultant services to the National Institute of Neurological Disorders and Stroke. The consultants will provide guidance and advice on biologics development processes for the Ultra-Rare Gene Therapy program, the NIH Blueprint Neurotherapeutics Biologics program, and other programs requiring therapeutic oligonucleotide expertise. Capability statements must include company information, NAICS codes, business size and status, capability and qualification information responding to requirements in the notice. Electronic capability statements are due by May 30, 2023 to polina.klimenkova@nih.gov with the subject "Capability Statement 75N95023Q00329."

There is no set-aside designation. Capability statements should include the relevant NAICS codes, and the notice is seeking small businesses. The services procured will provide subject matter expertise to multiple NIH programs focused on biologics and gene therapy development. The notice is for information purposes only and does not obligate the government to any specific number of awards or total budget for the potential future work.