Closed Solicitation · DEPARTMENT OF HEALTH AND HUMAN SERVICES
AI Summary
The Department of Health and Human Services, through the National Institutes of Health, is seeking sources for a drug manufacturing and formulation contract. This contract involves the complete manufacturing, documentation, formulation, packaging, and labeling of investigational drug products. Bidders must maintain technical capabilities and compliance with FDA, WHO, and other relevant guidelines. Interested parties should review the attached Statement of Work for detailed requirements and ensure they qualify as a "Qualified Vendor."
Please take a moment to thoroughly review the attached Statement of Work (SOW), which outlines the full scope and details of the drug formulation and manufacturing contract requirement.
The goal of the contract is to complete all the manufacturing, documentation, formulation, fill and finish, packaging, and labeling required for investigational drug products. Throughout the period of performance (PoP) of the contract, the contractor must maintain the technical capabilities, minimum resources and organizational compliances with which to successfully conduct any awarded contract activity. The contractor must also maintain a good standing as a “Qualified Vendor” as determined by ORSC. Additionally, unless otherwise requested, any assigned research must be performed in compliance with all current FDA, World Health Organization (WHO), USP, ISO, and International Committee on Harmonization (ICH) policies, practices, procedures, guidelines and regulations specific to current good manufacturing practices (cGMP) as may be applicable.
DRUG MANUFACTURING AND FORMULATION CONTRACT II is a federal acquisition solicitation issued by DEPARTMENT OF HEALTH AND HUMAN SERVICES. Review the full description, attachments, and submission requirements on SamSearch before the response deadline.
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