Loren Data's SAM Daily™

fbodaily.com
Home Today's SAM Search Archives Numbered Notes CBD Archives Subscribe
FBO DAILY ISSUE OF NOVEMBER 11, 2009 FBO #2909
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
 
Record
SN02000881-W 20091111/091109235117-afa3f8b44fda533abf8f15811381a310 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |
ECGrid: EDI VAN Interconnect ECGridOS: EDI Web Services Interconnect API Government Data Publications CBDDisk Subscribers
 Privacy Policy  Jenny in Wanderland!  © 1994-2024, Loren Data Corp.