SOLICITATION NOTICE
R -- Biological Therapeutics Product Development Subject Matter Expert Consultants
- Notice Date
- 1/15/2025 5:59:22 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- NIH-NINDS-CSS-75N95025Q00109
- Response Due
- 1/26/2025 10:00:00 PM
- Archive Date
- 02/11/2025
- Point of Contact
- Shayna Simpson, Kelly Dempsey
- E-Mail Address
-
shayna.simpson@nih.gov, kelly.dempsey@nih.gov
(shayna.simpson@nih.gov, kelly.dempsey@nih.gov)
- Description
- Attachment 01 Amend 1_CSS 75N95025Q00109 has been added on 1/15/25 to address questions related to this solicitation. The NINDS has a need for biological therapeutics development subject matter expert (SME) consultants to provide technical recommendations and advice that will support the translational development of novel therapeutics (Biologics) for NIH drug discovery and development programs. The support included in this contract will cover all aspects of drug discovery and development through the Phase 1 clinical trial, including but not limited to chemistry, manufacturing, and controls (CMC), assay development, pharmacokinetics and pharmacodynamics (PK/PD), absorption, distribution, metabolism, and excretion (ADME), toxicology, regulatory affairs, regulatory operations, medical writing, biostatistics, and quality assurance/quality control (QA/QC), and first-in-human trial planning and design. The NINDS is seeking vendors who can supply a broad array of Biologics subject matter experts, including all modalities and cell and gene therapies.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/03ae3675788844498ab252f5568c912b/view)
- Place of Performance
- Address: Bethesda, MD, USA
- Country: USA
- Country: USA
- Record
- SN07313608-F 20250117/250115230100 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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