Independent Auditing & GxP Assurance
Rigorous, impartial audits to ensure your systems, processes, and suppliers adhere to the highest global regulatory standards and are inspection-ready.
Schedule An AuditGMP · GCP · GLP
Independent audits across all GxP disciplines
Supplier Audits
On-site and remote vendor qualification globally
Mock Inspections
Pre-FDA/EMA inspection readiness assessment
CAPA Support
Post-audit corrective action planning and follow-up
Our Audit Methodology
We execute comprehensive, risk-based audits that transcend standard checklists. Our methodology identifies systemic risks, verifies data integrity, and promotes a culture of continuous improvement.
Supplier Governance
Qualification and oversight of critical suppliers (CMOs, CROs) to ensure alignment with regulatory mandates.
Internal System Audits
Objective assessments of your internal QMS, manufacturing processes, and IT systems to drive excellence.
Data Integrity Audits
Specialized audits focused on ALCOA+ principles, Part 11 compliance, and the integrity of your data lifecycle.
Mock Inspections
Simulations of FDA, EMA, or other health authority inspections to stress-test your systems and build organizational confidence.
GxP & ISO Audits
Comprehensive audits against standards like GMP, GCP, GLP, and ISO 13485 to maintain strict certification.
Due Diligence (M&A)
Conducting quality and compliance due diligence for mergers, acquisitions, and strategic investments.
Build Absolute Confidence in Your Quality
Partner with Akatalyst to establish robust, transparent, and continuous audit oversight.
Engage Our Team