Procurement Summary
Country : USA
Summary : Biological Therapeutics Product Development Subject Matter Expert Consultants
Deadline : 27 Jan 2025
Other Information
Notice Type : Tender
TOT Ref.No.: 112634423
Document Ref. No. : NIH-NINDS-CSS-75N95025Q00109
Competition : ICB
Financier : Self Financed
Purchaser Ownership : Public
Tender Value : Refer Document
Purchaser's Detail
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Login to see detailsTender Details
Description
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.
Active Contract Opportunity
Notice ID : NIH-NINDS-CSS-75N95025Q00109
Related Notice
Department/Ind. Agency : HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier : NATIONAL INSTITUTES OF HEALTH
Office: NATIONAL INSTITUTES OF HEALTH NIDA
General Information
Contract Opportunity Type: Combined Synopsis/Solicitation (Original)
Original Published Date: Jan 02, 2025 01:43 pm EST
Original Date Offers Due: Jan 27, 2025 01:00 am EST
Inactive Policy: 15 days after date offers due
Original Inactive Date: Feb 11, 2025
Initiative: None
Classification
Original Set Aside:
Product Service Code: R499 - SUPPORT- PROFESSIONAL: OTHER
NAICS Code: 541690 - Other Scientific and Technical Consulting Services
Place of Performance: Bethesda, MD USA
Documents
Tender Notice
NIH-NINDS-CSS-75N95025Q00109.pdf
Attachment-7-Information-and-Physical-Access-Sec.pdf
Attachment-6-NIH-Invoicing-Instructions-w-IPP.pdf
Attachment-5-Tech-Eval-Criteria.pdf
Attachment-4-Price-Template.xlsx
Attachment-3-Representations-and-Certification.pdf
Attachment-2-Additional-Terms-and-Conditions.pdf
Attachment-1-Statement-of-Work-Biologics.pdf