Your Path to Excelling in EMA, EU, MHRA, and FDA Inspections
Whether you are a biotech innovator, a pharmaceutical manufacturer, a Clinical Trial Sponsor, or Manufacturing or Wholesale Distribution Authorisation Holder the journey towards regulatory compliance and success is demanding. That is where our mock regulatory inspections come into play, offering an unmatched preparation strategy crafted by former EMA, EU, MHRA inspectors. Our services are designed to prepare your team for the rigorous scrutiny of regulatory inspections by adopting a formal assessment with a consultative approach.
Assess, Adapt, Achieve with Former Regulatory Inspectors
Drawing on our consultants’ experience as Regulatory Inspectors, we replicate real inspection conditions to comprehensively assess your compliance with MHRA, EU and PIC/S regulations. We provide recommendations to address any deficiencies and offer your team feedback and insights into the regulatory inspection process.
Comprehensive Readiness Assessment
Our mock inspections simulate the “hats on” intensity and scope of actual EMA, EU, MHRA, and FDA inspections. Through rigorous examination of your operational, quality, and compliance frameworks, we identify vulnerabilities and areas for improvement, with the added benefit of being able to offer recommendations on how to address areas of non-compliance.
Real-World Preparation
Beyond identifying gaps, our mock inspections empower your team with practical experience and insights. You will learn how to effectively navigate the inspection process, manage interactions with inspectors, how to turn negatives into positives and confidently showcase your mitigating actions and compliance control measures.
Why Choose EPiC for Your Mock Regulatory Inspections?
Expertise that Matters: Benefit from the experience of former regulators who know what it takes to conduct successful inspections.
Customised Solutions: Receive guidance and recommendations tailored to your organisation’s specific needs and regulatory targets.
Next Steps
Take the first step towards regulatory excellence and assurance. Contact us today to learn more about how our mock regulatory inspections can fortify your preparation efforts, align your operations with regulatory expectations, and pave the way for a successful inspection outcome.