MODIFICATION
R -- Validation Services - Solicitation 1
- Notice Date
- 9/25/2009
- Notice Type
- Modification/Amendment
- 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
- Response Due
- 10/23/2009 3:00:00 PM
- 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
(mbuchen@ncifcrf.gov, childebrand@ncifcrf.gov)
- Small Business Set-Aside
- N/A
- Description
- RFP for Validation Services This is a Solicitation 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/FCRF/S09-1362/listing.html)
- Place of Performance
- Address: National Cancer Institute at Frederick, Frederick, Maryland, 21702, United States
- Zip Code: 21702
- Zip Code: 21702
- Record
- SN01970323-W 20090927/090926000634-6fd73640207d5fe5d41b9f93ac28ae06 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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