Our Services
WE SPECIALISE in helping pharmaceutical and biotechnology companies, as well as other associated healthcare clients, to achieve and maintain regulatory compliance and excellent pharmaceutical quality systems, to best industry standards.
Mock Regulatory Inspections
Former regulatory Inspectors can perform mock EMA, EU, MHRA or FDA inspections to assess the readiness of a company to successfully host a regulatory inspection, or as part of an initial gap analysis as a site embarks on preparation for such an inspection.
Advice, Support & Guidance
EPIC Auditors has a broad range of experience across all aspects of the product lifecycle. This includes supporting new companies during the initial stages of product development into clinical trials, through commercial manufacture and distribution to advising on post marketing commitments and pharmacovigilance.
Remote Audits
During the Covid 19 pandemic, like the MHRA, and like many other businesses, EPIC Auditors has been providing remote support and auditing. Helping companies to meet the regulatory requirements and to develop the quality systems essential to support much needed clinical trials for various Covid 19 treatments.
Case Studies
Our recent projects and case studies showcase our adaptability across a broad spectrum of pharmaceutical disciplines and regulatory frameworks, highlighting our commitment to GXP excellence. Assignments in all parts of the World will be considered, subject to security and visa implications, reflecting our dedication to promoting a culture of continuous improvement and compliance on a global scale.
Case Study 1: Inspection Readiness
EPiC received a request for support from a US-based pharma company that wanted a mock EU GMP inspection of their R&D facility. The company needed to assess compliance and inspection readiness for an anticipated EU GMP regulatory inspection by an EU regulatory agency.
Case Study 2: GMP Consultancy
EPiC received a request for support from a UK-based aseptic compounding unit to provide GMP consultancy to help the company respond to Critical and Major inspection deficiencies identified during a short-notice MHRA GMP inspection.
Case Study 3: Facility Plan Review
EPiC received a request from a manufacturer of non-sterile IMPs to review plans for a new facility. The new site had an established footprint and the client had designed the manufacturing rooms and supporting areas to fit the space but wanted an expert review of the plans to assess their compliance with EU GMP requirements…
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Case Study 4: Product Safety and Pharmacovigilance (PV) System
EPiC received a request from a large pharma group of companies that, following a series of mergers and acquisitions, was establishing a new UK entity and needed to establish a standalone PV system for the new entity in preparation for the transition.
Case Study 5: Corporate Audit Programme Support
EPiC received a request from a multinational speciality pharma company to provide expertise and resources to support their corporate audit program.
Case Study 6: Mock EU GMP Inspection & Remediation
Epic received a request from a pharmaceutical company in China that had invested in a new sterile product manufacturing facility and wanted to gain regulatory approval to supply products to the UK and EU.
Testimonials
See what our clients say about us and our services.