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
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.
GXP Audits
We support your internal, corporate and supply chain audit programs, helping you meet your quality oversight obligations. All our audits are carefully planned and carried out, focusing on GXP compliance, risk management and process improvement. With decades of auditing experience our consultants bring unmatched expertise to your team.
GXP Gap Assessments
Understanding that every organisation is different, we use our expert knowledge to evaluate your systems, processes and procedures against specific regulatory requirements to highlight gaps and propose solutions to meet and enhance regulatory compliance.
GXP Training and Education
Our experts use their industry experience and technical knowledge to educate and mentor your staff, including Senior Managers, on GXP requirements and the importance of compliance. We will support you in ensuring your personnel are trained and competent to generate reliable clinical trials data and manufacture and supply safe and effective products.
GXP Remediation, Advice & Suport
We offer bespoke expert support tailored to your specific business, licensing, and GXP regulatory needs, from responding to specific questions and non-conformances to guiding post-inspection remediation. As former regulators we ensure your response to compliance issues and adverse inspection findings is risk based, thorough and effective.
Contract QP, RP, RPI and Compliance Monitor Services
We provide experienced and qualified personnel to support you in meeting your regulatory obligations. Many of our consultants are eligible to be named on Manufacturing and Wholesale Dealer Licences and a number are eligible to act as Compliance Monitors.
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
A UK-based manufacturer of aseptic unlicensed medicines received critical and major inspection deficiencies following an unexpected MHRA GMP inspection. EPiC were asked to provide GMP consultancy to help the company respond to IAG.
Case Study 3: Facility Plan Review
A manufacturer of non-sterile IMPs asked EPiC 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 before any building work was undertaken.
Testimonials
See what our clients say about us and our services.