Medical Device, IVD & Pharmaceutical Regulatory and Quality Compliance
Practical Quality Assurance and Regulatory Affairs consulting to help medical device and life sciences companies achieve compliance, accelerate market access, and drive success.
Welcome to GJA Consulting LLC
Established in March 2025, GJA Consulting LLC provides experienced, practical Quality and Regulatory support to medical device and life sciences companies.
We bring decades of real-world experience across quality systems, regulatory submissions, compliance, audits, risk management, CAPA, technical documentation, and global market access.
Learn more about usHow We Help
510(k) Support
End-to-end 510(k) submission support, documentation development, and FDA submission assistance.
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QMS implementation, remediation, CAPA, risk management, audits, and regulatory strategy.
Learn moreGlobal Regulatory
EU MDR & EUDAMED registration support and product registrations in 85+ countries.
Learn moreQuality Store
SOPs, Quality Manuals, Templates, Training Materials and QMS Implementation Tools.
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