SOURCES SOUGHT
R -- Regulatory Affairs Support Services
- Notice Date
- 11/9/2009
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH-10-DRB001
- Response Due
- 11/24/2009
- Archive Date
- 1/23/2010
- Point of Contact
- Donna R. Blackstone, 301-619-2276
- E-Mail Address
-
US Army Medical Research Acquisition Activity
(donna.blackstone@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- SOURCES SOUGHT for Regulatory Affairs Support Services. The scope of work includes, but is not limited to: preparation and assembly of Investigational New Drug applications (INDs)/Investigational Device Exemption applications (IDEs) and IND/IDE related documents; preparation and assembly of Pre-Market Notifications (510(k)s), Pre-Market Approval applications (PMAs), Biological License Application (BLA), New Drug Applications (NDAs), Environmental Protection Agency (EPA) registration packages, and related documents; data base management (i.e. electronic cataloging and storage capabilities of INDs, NDAs, IDEs, 510(k)s, PMAs and EPA registration packages; post marketing surveillance for NDAs and PMAs; suitability assessments of data to support regulatory filings; audit capability encompassing clinical trials, preclinical trials, assay development and validation, and product manufacturing to include compliance with current Good Clinical Practices (cGCP), current Good Laboratory Practices (cGLP), and current Good Manufacturing Practices (cGMP); capable of Common Technical Data (CTD) packages and/or electronic Technical Data Packages (eCTD); capable of in-house eCTD Readiness and Document Processing by demonstrating the ability to convert paper documents to electronic documents regarding compliance to the latest eSubmission requirements. Have a proven track record of successful submission through to the FDA; support all lifecycle management of eINDs through NDA or BLA submission; provide all documents to the Government eSubmission ready; support a secure collaborative website for the exchange of eSubmissions and collaborative work groups; and compliance with all CFR and FDA guidelines. Place of performance is both on and off a Government Facility. THIS IS A SOURCES SOUGHT SYNOPSIS ONLY. THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. PROPOSALS ARE NOT REQUESTED AT THIS TIME AND WILL NOT BE CONSIDERED. Any information submitted is voluntary. The Government will not pay for any information that is submitted in response to this sources sought synopsis. The Government intends to conduct Capability Presentations 15-17 December 2009. Respondents who have provided documentation that appears capable of satisfying the requirements stated herein will receive notification of the date and time of their scheduled presentation. Along with documentation supporting capability assertions (including recent past performance contract and contact information), the respondent shall provide a narrative identifying business size (small business, small disadvantaged business, or large business), and applicable designators (service-disabled veteran-owned, HUBzone, woman-owned, etc.). The applicable NAICS is 541990 - Small Business Size Standard is $7.0M. All responses must be received by 4:00 p.m. Eastern, Tuesday, 24 November 2009. Narratives should be e-mailed to Mrs. Donna Blackstone at Donna.Blackstone@us.army.mil. Telephonic inquiries shall not be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH-10-DRB001/listing.html)
- Place of Performance
- Address: US Army Medical Research Acquisition Activity ATTN: MCMR-AAA, 820 Chandler Street Frederick MD
- Zip Code: 21702-5014
- Zip Code: 21702-5014
- Record
- SN02000881-W 20091111/091109235117-afa3f8b44fda533abf8f15811381a310 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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