Food and Drug Administration (FDA) Regulatory Compliance Training
SAM.GOV Due: April 18, 2025 at 06:00 PM UTC
In-Active Combined Synopsis/Solicitation SBA Source Url

Summary

The Food and Drug Administration (FDA) Regulatory Compliance Training opportunity is aimed at providing essential competency training for personnel involved in FDA-regulated research activities within the U.S. Army Medical Research and Development Command (USAMRDC). This training encompasses critical areas such as Good Clinical Practices (GCP), Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and Quality Systems Regulations (QSR). The objective is to ensure that all individuals engaged in FDA-regulated studies possess the necessary education, training, and experience to comply with federal regulations and maintain competency in product development efforts. Contractors with expertise in regulatory compliance training, particularly those familiar with FDA regulations and military research environments, are encouraged to bid on this opportunity, which is set aside for small businesses.
Description

This requirement provides competency training for personnel involved in FDA regulated research activities. The USAMRDC requires FDA regulated training in the areas of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP) and Quality Systems Re

Entities
DOD
Department of Defense
DHA(
Defense Health Agency
NAICS
541990
Set Aside
SBA : Total Small Business Set-Aside (FAR 19.5)
Place of Performance
Frederick , Maryland 21702
Point of Contact
Full Name Email Phone Type
Matthew Gembe [email protected] 3016191350 primary
Attachments
  • B08+Attachment+3+-+Past+Performance+References.pdf
  • B08+Attachment+2+-+Organizational+Conflict+of+Interest+Certification+Form.docx
  • B08.+HT9425-25-R-0050%2BRFP+Amendment+0001.docx
  • B08+Attachment+1+-+Non-Disclosure+Agreement.docx
  • B08+Pricing+Sheet+-+Attachment+4.xlsx