SOURCES SOUGHT
R -- FDA Regulatory Affairs Specialist
- Notice Date
- 12/9/2008
- Notice Type
- Sources Sought
- NAICS
- 541110
— Offices of Lawyers
- Contracting Office
- Department of Veterans Affairs;VA Boston Healthcare System;Contracting Officer (90C);940 Belmont Street;Brockton MA 02301
- ZIP Code
- 02301
- Solicitation Number
- VA-241-09-RP-0085
- Response Due
- 12/12/2008
- Archive Date
- 12/13/2008
- Point of Contact
- Laurie CordeiroContract Specialist<br />
- Small Business Set-Aside
- N/A
- Description
- The Department of Veterans Affairs, VA Boston Healthcare System, has a requirement to procure the services of a regulatory affairs specialist. The Center for Innovative Visual Rehabilitation (hereafter "CIVR") requires the services of a regulatory affairs specialist to facilitate obtaining an approved IDE (Investigational Device Exemption) from the U.S. Food and Drug Administration (FDA) in order to commence clinical studies to support the U.S. FDA pre-market approval of the CIVR implant. There will be a phased effort, to include: 1) Identification of an effective regulatory strategy; 2) Early interaction and feedback from the FDA through a pre-IDE meeting; and 3) Development of an initial clinical trial strategy based on this FDA feedback. A fixed price requirements contract is anticipated and shall be awarded. This is a sources sought notice. Concerns having the expertise and required capabilities to meet this requirement are invited to submit complete and current information showing their capabilities within 3 calendar days from the day this notice is published. Concerns that respond to this notice must fully demonstrate the capability to accomplish the above requirement. This is not a solicitation; this is a sources sought notice only. Inquires /information received after the established deadline shall not be considered. All communication regarding this requirement shall be via email to the contracting specialist listed. The Government does not intend to pay for information solicited. This synopsis is issued pursuant to FAR 6.101.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=febc16dfdfc5f2794c8b8b154181d917&tab=core&_cview=1)
- Record
- SN01716234-W 20081211/081209220617-febc16dfdfc5f2794c8b8b154181d917 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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