Global Mock Inspection Services
Regulatory mock inspections are a routine part of life in pharma and biotech. At Apotech, we see them as an opportunity to prove your quality systems are doing their job: protecting patients and your data. We help you move away from "inspection panic" and toward a culture of permanent readiness.
Our senior-led team provides realistic mock inspections that mirror exactly how the FDA, EMA, and MHRA work. We handle the heavy lifting of compliance, giving you clear, practical steps to stay ahead.
Why Mock Inspections matter
Regulators want to see if your Quality Management System (QMS) actually works in the real world. A mock regulatory inspection tests your systems under the same pressure as a real audit. We focus on what matters most: data integrity, management oversight, and your CAPA systems.
Instead of just checking boxes, we look at how your team handles challenges and escalates risks. This ensures your operations aren't just compliant on paper, but defensible in person.
Keep learning: Explore our guide for GxP best practice explained, or see our GMP inspection data insights
When to Schedule a Mock Inspection
Most organizations plan a pharma mock inspection during these key moments:
- Before a deadline: Preparing for a scheduled FDA, EMA, or MHRA filing or your first GMP audit.
- After an audit finding: Making sure your corrective actions actually fixed the problem and will stand up to a follow-up.
- During big changes: Keeping control while scaling up, merging, or changing your global structure.
How Our Process Works
- The Readiness Review
We start with a simple assessment of your current gaps. This often works alongside our Quality Assurance support to give you a full picture of your compliance.
- The Simulation
We run a realistic mock FDA audit, including facility tours and document reviews. We tailor the scope to your specific product and risk level. You can see how we apply these standards in our GMP audit case study.
- Interview Coaching
The way your team speaks to an auditor is vital. We provide friendly, expert coaching to help your SMEs stay calm, clear, and technically precise during interviews.
- Practical Reporting
We don’t give you fluff. You’ll receive a report structured just like a real regulator’s findings, with a clear plan for remediation support.
We have experience conducting mock inspections with the following authorities:
- FDA (USA)
- MHRA (UK)
- EMA (EU)
- Health Canada
- TGA (Australia)
- Swissmedic (Switzerland)
- ANSM (France)
- PMDA (Japan)
- CDSCO (India)
- NMPA (China)
- ANVISA (Brazil)
- SAHPRA (South Africa)
- HSA (Singapore)
Trusted by top-tier teams worldwide
650+
Audits conducted in the last year
800
Network of expert GxP auditors
110
Countries covered
Why choose Apotech for mock inspections?
Our onsite or remote mock inspections help pharmaceutical, biotechnology, and medical device companies maintain the highest standards of readiness. Leveraging our deep in-house experience, we provide tailored simulations you can trust.
Global Inspection Specialists
Our network of 800+ senior consultants covers all GxP disciplines worldwide. We provide mock inspections with local-language fluency, ensuring your team is prepared for specific regional regulator behaviors.
Regulatory and Mock Inspection Expertise
Our specialists bring real-world experience from within the FDA, EMA, and MHRA, or from leading large-scale remediation. With a minimum of 20 years of experience, our team members have led hundreds of successful simulations across the life sciences sector.
Competitive Pricing
By utilizing our local consultant network, we minimize travel and expense costs. This keeps our mock inspections cost-effective without compromising on the seniority of the team reviewing your systems.
Flexible, Client-Centered Service
From targeted "for-cause" simulations to global readiness programs, we adapt to your timeline and budget. Our dedicated Project Manager model ensures seamless scheduling and constant alignment with your internal stakeholders.
Featured case studies
GMP QA Consulting
GMP QA Consulting Introduction Global API Manufacturer The client was an API manufacturer, with a need for some support to cope with a deviation backlog. Apotech consultant: Two QA Consultants, with backgrounds in sterile devices. Types of Audits GMP Tools: Ishikawa, 5M Audit Locations Europe Scope of work Under the QA director supervision, our consultant…
Batch Release as EU Qualified Person
Batch Release as EU Qualified Person Introduction Our client is a vertically integrated company in chemical synthesis and manufacturing of generic Active Pharmaceutical Ingredients and Drug Products. Standards and references Scope of work Remote batch certification and release of medicinal products Provide regulatory expertise as requested Review Marketing Authorisation variations Perform training with impacted…
FAQs on mock inspections
At Apotech, we offer full transparency on our mock inspection services. We aim to make the process as simple to understand as possible and are always on hand to answer any questions you might have.
Here are some of the questions we get asked most often.
Helpful resources
2024 Pharmaceutical Inspections: Risk-Based, Remote-Ready, and Globally Harmonized
Staying audit-ready is no longer optional, it’s strategic! Based on EFPIA’s 2024 Inspection Survey, pharmaceutical manufacturers must align with increasingly global and risk-based inspection models. At Apotech, we help clients confidently meet these evolving expectations. Inspection compliance is consistent: no matter the type Whether a Pre-Approval Inspection (PAI), routine check, for-cause investigation, or surveillance audit,…
What is QMSR vs QSR? Understanding The FDA Final Rule and ISO 13485 Harmonization
The Quality Management System Regulation (QMSR) is the U.S. Food and Drug Administration’s (FDA) new rule replacing the Quality System Regulation (QSR) for medical devices. Finalized in February 2024, QMSR updates 21 CFR Part 820 by incorporating ISO 13485:2016 by reference, aligning U.S. quality system requirements with the internationally recognized medical device standard while retaining certain FDA-specific obligations. The…
How To Master The CAPA Process Step-by-Step: From Identification to Implementation
The Corrective and Preventive Action (CAPA) process is a core mechanism within Pharmaceutical and Biotech quality systems, designed to identify, address, and prevent issues that may impact compliance, product quality, and most importantly, patient safety. In regulated environments, CAPAs are not isolated actions but structured responses embedded within a wider quality management framework. CAPAs are commonly triggered by internal…