SOURCES SOUGHT
R -- Validation Services
- Notice Date
- 4/15/2009
- Notice Type
- Sources Sought
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Bldg 427, Room 12, Frederick, Maryland, 21702
- ZIP Code
- 21702
- Solicitation Number
- S09-1362
- Point of Contact
- Marilyn H Buchen,, Phone: (301)846-1527, Chad R Hildebrand,, Phone: (301) 846-5422
- E-Mail Address
-
mbuchen@ncifcrf.gov, childebrand@ncifcrf.gov
- Small Business Set-Aside
- N/A
- Description
- This is a sources sought announcement for Validation Services at the National Cancer Institute at Frederick. SAIC-Frederick., Operations and Technical Support Contractor for the National Cancer Institute at Frederick (NCI-Frederick) under Contract number HHSN261200800001E requires Validation Services for the Advanced Technology Research Facility (ATRF). The ATRF manufactures biopharmaceuticals in compliance with FDA cGMP regulations. These biopharmaceuticals are used in pre-clinical studies and investigational Phase 1, 2, and non-pivotal Phase 3 clinical trials. The Validation subcontractor will support the ATRF in qualification and validation of a new facility, utilities, and equipment. In addition, the subcontractor will prepare, submit, and present data, analysis, reports, and documents as needed and will be responsible for the control, processing and safekeeping of protocols,, data reduction and analysis records, reports and validation packages and other documentation. The Validation subcontractor will also be responsible to prepare Validation Master Plans, utility and equipment-specific SOPs, IQ/OQ/PQ protocols, Final Validation Reports and related documents that meet FDA 21CFR 211 and 610, and other international and federal regulations Offerors will be required to demonstrate relevant experience, appropriate certifications, necessary personnel, and adequate management procedures. Interested business concerns should register their interest at this website by clicking “ADD ME TO INTERESTED VENDORS’ and completing the information required. No collect calls will be accepted. No facsimile transmissions will be accepted. Telephone inquiries are discouraged. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. This notice is for information and planning purposes only and does not commit SAIC-F to award a contract now or in the future. THIS IS NOT A REQUEST FOR PROPOSALS. SAIC-F does not intend to award a contract based on responses under this announcement; however, a Request for Proposal is projected to be released in the early summer of 2009.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=f5d4106708db23ea0f18e65132f70062&tab=core&_cview=1)
- Place of Performance
- Address: National Cancer Institute at Frederick, Frederick, Maryland, 21702, United States
- Zip Code: 21702
- Zip Code: 21702
- Record
- SN01794222-W 20090417/090415225520-f5d4106708db23ea0f18e65132f70062 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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