Quality Assurance & Regulatory Compliance Experts for the Life Science Industry
Quality System Remediation, Staff Augmentation & GxP Auditing for Pharmaceutical, Medical Device, Biotech, & Diagnostics Companies and the Companies that Support Them
Our experts become an extension of your team to help uncover the root cause of compliance issues, remediate them, and prevent recurrence so you are FDA ready.
Reduce FDA inspection risk while you continue to focus on your business objectives. We provide GxP Auditing, Inspection Readiness, Mock FDA Audit, GAP Analysis, Validation, and more.
With a vast network of FDA expert witnesses, we can help attorneys with everything from document review and written expert reports to trial appearances and testimony.
ABOUT
Premier FDA Solutions
Our mission is to help ensure the quality and availability of life-saving and life-enhancing products to people in need throughout the world. Our sole focus at Premier FDA Solutions is to support the cutting-edge risk-takers (and the companies that support them) who develop the world’s best health innovations. Contact us today to learn more about our FDA regulatory compliance consulting services.
Our Blog
Guide To IQ, OQ, and PQ In FDA-Regulated Industries
In FDA-regulated industries, there are a variety of standardized qualifications that a product must meet post-manufacture. In the Life Sciences industry, that means medical devices go through a series of ...
How The Life Science Industry Can Remain FDA Compliant in 2022
The coronavirus pandemic was a deeply disruptive, global event that sent ripples through just about every industry and occupation. While the Life Science industry has played a central role in ...
Quality and the Pharma-CMO Relationship
Just how connected are quality and the pharma-CMO relationship? As the FDA begins to rein in the regulatory free-for-all that was the COVID-19 emergency use authorization (EUA) process, it ...
