Auditing That Strengthens Control and Keeps You Inspection-Ready
Meet audit requirements without pulling experts away from daily operations. Former EMA and authority inspectors deliver audits that reveal fundamental gaps, strengthen processes, and keep you inspection-ready year-round.
Common challenges in auditing
Limited internal capacity to meet audit plans
Most organizations plan supplier audits, internal reviews, and follow-ups throughout the year. But when auditors are pulled into production issues, leave unexpectedly, or face competing priorities, planned audits are delayed.
What begins as a manageable schedule becomes a year-end scramble to complete mandatory audits before authorities review compliance.
Regulatory requirements with fixed timelines
Pharma and medtech companies must demonstrate control over suppliers and internal processes through documented audits. During inspections, authorities check whether your audit plan was completed as written.
Missing or delayed audits create findings, and incomplete supplier audits can delay product releases. These requirements do not adjust for resource constraints.
Auditing requires both technical depth and auditor skill
Effective audits demand expertise in the area under review and the ability to conduct interviews, challenge assumptions, and identify gaps others miss. Many technical experts understand what should happen, but lack auditing skills. Developing strong auditors takes years, and few organizations have the capacity to grow this internally.
Independence requirements prevent auditing one’s own work
Quality must audit quality. IT must audit IT. Yet regulatory standards require independence – meaning teams cannot audit their own work. When internal auditors all sit in the same department, organizations need external support to maintain compliance and objective oversight.
We solve this by
Mock inspections for authority readiness
We conduct simulated regulatory inspections to assess whether your systems, documentation, and teams are ready for FDA, EMA, or other authority visits. Mock inspections reveal gaps early and include coaching to strengthen weak areas.
Supplier audits delivered as third-party capacity
Professional supplier audits performed on your behalf to meet regulatory requirements and annual audit plans. We conduct on-site reviews, document findings, and deliver reports you can use directly in your QMS.
Independent internal audits
Get an objective review of your processes, systems, and operations. We bring technical depth and auditing expertise to identify risks, improvement opportunities, and compliance gaps that internal teams cannot review on their own.
Flexible support when audit plans fall behind
We offer step-in capacity to accommodate unexpected events that disrupt your schedule. Whether you need a single urgent supplier audit or coverage across multiple reviews, we adapt to your timeline and requirements.
Ready to strengthen your audit approach?
What this looks like in practice
Audit plans completed on schedule
Regulatory commitments are met without last-minute pressure. Suppliers are reviewed as planned, internal processes receive objective oversight, and documentation stays current.
Inspection-ready operations year-round
Mock inspections allow gaps to be bridged before authorities arrive. Teams know what to expect, documentation reflects reality, and inspections confirm readiness rather than exposing risk.
Independent findings that drive improvement
Audits deliver a clear, objective assessment rather than simply confirming existing practices. Findings highlight practical steps to strengthen processes, reduce risk, and improve compliance.
Expertise available when needed
Specialized auditing skills are accessible without long-term hiring commitments. Organizations get the technical depth required for complex audits when they need it most.
Hear from our clients
Practical results delivered through deep life science expertise.
Why life science companies choose Epista
Professional auditors with technical expertise
Our auditors combine decades of GMP, quality, and regulatory experience with proven auditing skills. This means findings are credible, actionable, and grounded in real-world operations.
Regulatoy authority experience on the team
We know what inspectors focus on, how they evaluate evidence, and what distinguishes adequate compliance from genuine control.
Training grounded in real audit experience
Insights from audits feed directly into our training programs, and training engagements often reveal opportunities for audit support. This combination gives our clients a deeper understanding and more effective remediation.
Flexible capacity for unexpected needs
We step in when audit plans fall behind, when key auditors are unavailable, or when supplier issues require immediate review. You get the expertise you need, exactly when you need it.
Training shaped by what authorities actually expect
Epista’s auditors also deliver training programs grounded in real inspection findings. Because we conduct hundreds of audits each year across pharma, biotech, and medtech, our instructors bring direct insight into what authorities expect and where organizations typically struggle. Training reflects real regulatory expectations – not outdated theory or generic frameworks.
Meet your auditors
Epista’s auditors have conducted hundreds of supplier, internal, and mock inspections across six continents. Many are former authority inspectors, Quality Heads, and GMP specialists who now focus on helping organizations strengthen compliance and operational control.
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GMP (Drug Substance and Drug Product), aseptic manufacturing. 100+ audits, 10,000+ on-site hours. Hosted FDA, Japan, China, Brazil, and EU inspections. ISO13485 certified Lead Auditor
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ISO13485 certified auditor, including MDSAP. 20+ years in medtech compliance. Experience in hosting and preparing organizations for authority and notified body inspections
GMP and GDP specialist. 50+ audits across Europe, China, Japan, and the US. Former Head of QA, QP, RP, and QPPV
