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.
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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.
Our Blog
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 has ...
Why You Need a Strategy for QMS Oversight in the post-COVID Era
The temporary halt of routine onsite FDA inspections in early 2020 forced some drug and device manufacturers into product development limbo, and others had to rethink their strategy for QMS ...
Remote GxP Inspections
Remote FDA Inspection Audit Maintaining GMP and GCP Inspection Readiness in a Remote-Audit World Medical device, pharmaceutical and life science companies are feeling the impact as the coronavirus pandemic ...
