Small Molecules and / or Biologics Regulatory Affairs Subject Matter Expert Support Services
Past New Requirement Updated
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $250,000 to $700,000
- Set-aside
- Total Small Business
Forecast facts
- Anticipated award
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Points of contact
-
- Nagarajan Rangarajan nagarajan.rangarajan@nih.gov
- Daniel Federline daniel.federline@nih.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The Department of Health and Human Services National Institutes of Health plans to procure small molecule and biologics regulatory affairs subject matter expert support services under a total small business set-aside, with an estimated solicitation release date of March 1, 2026 and an estimated award date of September 1, 2026. These subject matter experts support the BPN and HEAL small molecule programs, which use retired executive-level scientific managers from pharma to guide principal investigators through drug development for neurological diseases and non-opioid pain medications. The source describes these contracts as essential, because programs that have completed FDA IND applications and progressed to Phase 1 trials depend on them.
Contracts are structured as one-year labor contracts with two option years and fall under the Simplified Acquisition Threshold, with an estimated award value range of $250,000 to $700,000 under NAICS 541715 (Research and Development in the Physical, Engineering, and Life Sciences, except Nanotechnology and Biotechnology). Points of contact are Contracting Officer Daniel Federline (daniel.federline@nih.gov) and Nagarajan Rangarajan (nagarajan.rangarajan@nih.gov), both at NIH. Both estimated dates precede this forecast's November 14, 2026 posting date.
Forecast text
BPN small molecule and HEAL programmes have been in operation for more than 13 years. The aim of these programmes is to accelerate the development of drugs for neurological diseases and non-opioid pain medications. The programmes guide PIs through the drug development process using a number of retired executive level, scientic managers from Pharma. A number of BPN and HEAL projects have successfully completed FDA IND applications and progressed to Phase 1 trials. A number of projects have been purchased by venture capital and pharma companies. SMEs in various disciplines such as Regulatory Affairs are engaged on 1-year labor contracts with 2 option years. These are small business contracts under Simplified Acquisition Threshold . These are essential contracts without which current and future drug development projects will not be able to progress.
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