At EPiC, we understand that navigating GxP compliance, good practice guidance, and regulatory requirements can feel overwhelming, especially in fast‑moving pharmaceutical and healthcare environments.
Our FAQ’s brings together clear, practical answers to the queries we receive most often from clients across the UK and worldwide. Whether you’re preparing for a GMP or GDP audit, strengthening your Quality Management System, or seeking expert support on inspection readiness, this resource is designed to give you confidence, clarity, and immediate guidance.
Explore the sections below to learn more about our auditing approach, training services, compliance standards, and how EPiC helps organisations meet and exceed industry expectations. If you need further support, our team is always ready to help.
EPiC are a team of former MHRA inspectors and industry experts providing specialist GxP compliance services to the pharmaceutical, biotech, and healthcare sectors. We help protect patients by helping you meet regulatory expectations and improve quality systems.
EPiC offer a wide range of services including GxP audits, mock regulatory inspections, gap assessments, training and education, remediation support, and contract QP/RP/RPi services. See our services page here: Services
The EPiC team includes over 50 former regulators and senior industry professionals with real-world experience. We combine regulatory insight with practical, risk-based solutions tailored to your business.
EPiC support pharmaceutical manufacturers, biotech companies, advanced therapy medicinal products (ATMPs), clinical trial sponsors, wholesalers, and hospital manufacturing units across the UK and internationally. Our consultants are familiar with UK and international regulatory frameworks such as EMA, FDA, and PIC/S.
Yes, EPiC offer mock inspections, inspection readiness training, and gap assessments to ensure your team and systems are fully prepared for regulatory scrutiny.
EPiC provide tailored training, mentoring, and strategic advice to embed a culture of quality and compliance throughout your pharmaceutical manufacturing organisation from the top down.
Next Steps
If you have further questions or need tailored support, our team is ready to guide you through the next steps with clarity and confidence.