Our solutions
GxP Auditing & Assessments
Whether you’re preparing for a regulatory inspection, undergoing a vendor qualification audit, or conducting internal risk-based assessments, Pharmalyn Consulting provides comprehensive GxP audit services that uncover gaps, strengthen compliance, and reduce regulatory risks
Our experienced auditors evaluate your systems, processes, and third-party partners against current regulatory expectations, including EU GMP, FDA CFRs, Annex 11, and ICH Q10 frameworks.
What we offer
- Independent audits of internal systems and procedures
- Supplier and third-party audits (including virtual audits)
- Pre-inspection readiness assessments
- Audit remediation planning and support
- Risk-based audit programs aligned with your QMS
We don’t just point out problems, we provide clear, actionable guidance to help you resolve findings efficiently and build a stronger, more resilient compliance posture.
Know where you stand and how to improve