Independent Auditing & GxP Assurance
Delivering rigorous, impartial auditing services to ensure your systems, processes, and suppliers adhere to the highest global regulatory standards.
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. We partner with you to build a resilient, inspection-ready quality framework, not just prepare for a single event.
Core Audit & Assurance Services
Supplier & Vendor Governance
Qualification and ongoing oversight of critical suppliers (CMOs, CROs, software vendors) to ensure alignment with your quality and regulatory mandates.
Internal Process & System Audits
Objective assessments of your internal QMS, manufacturing processes, and IT systems to identify gaps and drive operational excellence.
Data Integrity & Governance Audits
Specialized audits focused on ALCOA+ principles, 21 CFR Part 11/Annex 11 compliance, and the integrity of your GxP data lifecycle.
Mock Regulatory Inspections
Simulations of FDA, EMA, or other health authority inspections to stress-test your systems, prepare your team, and build organizational confidence.
GxP & ISO Standard Audits
Comprehensive audits against standards like GMP, GCP, GLP, and ISO 13485 to ensure adherence and maintain certification.
Due Diligence for M&A
Conducting quality and compliance due diligence for mergers, acquisitions, and strategic investments.
Ready to Enhance Your Compliance Framework?
Let's build a resilient, efficient, and inspection-ready future for your organization. Schedule a complimentary, no-obligation consultation with our experts to discuss your specific challenges and discover how Akatalyst can be your catalyst for success.
Our Product Suite
Our pre-validated, GxP-compliant software simplifies quality management, with an optional AI layer to unlock next-gen efficiency.
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