Biological Therapeutics Product Development Subject Matter Expert Consultants
| Location: | Maryland |
|---|---|
| Posted: | Jan 15, 2025 |
| Due: | Jan 27, 2025 |
| Agency: | HEALTH AND HUMAN SERVICES, DEPARTMENT OF |
| Type of Government: | Federal |
| Category: |
|
| Solicitation No: | NIH-NINDS-CSS-75N95025Q00109 |
| Publication URL: | To access bid details, please log in. |
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- Contract Opportunity Type: Combined Synopsis/Solicitation (Updated)
- Updated Published Date: Jan 15, 2025 08:59 am EST
- Original Published Date: Jan 02, 2025 01:43 pm EST
- Updated Date Offers Due: Jan 27, 2025 01:00 am EST
- Original Date Offers Due: Jan 27, 2025 01:00 am EST
- Inactive Policy: 15 days after date offers due
- Updated Inactive Date: Feb 11, 2025
- Original Inactive Date: Feb 11, 2025
-
Initiative:
- None
- Original Set Aside:
- Product Service Code: R499 - SUPPORT- PROFESSIONAL: OTHER
-
NAICS Code:
- 541690 - Other Scientific and Technical Consulting Services
-
Place of Performance:
Bethesda , MDUSA
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.
- c/o 3WFN MSC 6012 301 N Stonestreet Ave
- Bethesda , MD 20892
- USA
- Shayna Simpson
- shayna.simpson@nih.gov
- Kelly Dempsey
- kelly.dempsey@nih.gov
- Jan 15, 2025 08:59 am ESTCombined Synopsis/Solicitation (Updated)
- Jan 02, 2025 01:43 pm EST Combined Synopsis/Solicitation (Original)
Related Document
| Jan 2, 2025 | [Combined Synopsis/Solicitation (Original)] Biological Therapeutics Product Development Subject Matter Expert Consultants |
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