ABOUT BDRA CONSULTING LLC
At the Forefront
BRDA Consulting is a US FDA Regulatory and Quality Management consulting firm specializing in Devices, Diagnostics, and Combination Products.
Established in 2012, BRDA develops marketing authorization applications, conducts quality systems audits and provides regulatory strategy advice to startups and small businesses.
Conveniently located in Maryland less than 20 miles from the FDA
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BDRA CONSULTING LLC SERVICES
Discover Our Expertise
REGULATORY
Expert Regulatory Guidance
We provide comprehensive support for our client’s product development needs. Our expertise includes:
• Regulatory Strategy Development
• Regulatory plans
• Regulatory Gap assessments
• FDA Pre-submissions, including Pre-IND submissions for combination products
• Medical Device regulatory
• In vitro Diagnostics
• Software as a Medical Device (SAMD)
• Combination Products, Drug-Device and Drug Biologics submission
• Assist with IDE, IND, 510k, de novo, PMA, and 505(b)(2).
QUALITY
Expert Quality System Guidance
Looking to build a quality system but not sure where to turn?
We also specialize in evaluating a client’s quality management systems. We have conducted:
Quality Systems Audits
Quality Systems Gap Assessments
Establishing FDA 820 Compliant Quality Systems
