This Government Contract opportunity was posted on August 23, 2012. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Regulatory Filing Support for the Development of Medications
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
Active Opportunities Like This One
AI Contract Overview
The National Institute on Drug Abuse is soliciting proposals under RFP N01DA-12-8902 for regulatory filing support to assist in the development of medications. This procurement is a 100 percent set-aside for Service-Disabled Veteran-Owned Small Businesses under NAICS code 541990. The selected contractor will be responsible for preparing, compiling, indexing, and filing various regulatory documents, including Initial Investigational New Drug applications, New Drug Application submissions, annual reports, and protocol amendments. All work must adhere to FDA regulations, International Conference on Harmonization guidances, and Good Clinical Practice guidelines. The government intends to award a single cost-reimbursement indefinite delivery, indefinite quantity contract with options for additional work and at least one anticipated task order. Amendment 1 to the RFP was issued to update the title, revise the Statement of Work, and clarify submission methods to the FDA. Interested parties must follow the guidelines provided in the RFP package, and the government has specified that it is not utilizing commercial item acquisition policies for this specific procurement.
General Info
Agency
Contract Value
$483,563.45Place of Performance
MD, USASet-Aside
Award Issued Date
Documents
0AI Contract Breakdown
Uniform Contract FormatNo documents to break down
The breakdown needs solicitation documents. None were found from this contract's source.
Timeline
Submission Closed
Organization & Contact Information
Full Description
Find Active Opportunities Like This
Get AI-powered intelligence on the opportunities still open
Every page of the solicitation package shredded into a compliance breakdown
AI-powered matching based on your capabilities and past performance
Competitor and incumbent history on the requirement
Automated alerts on amendments, Q&A deadlines, and award
Join 750+ contractors already using CLEATUS
