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Pharma Compliance Consulting | Ex MHRA InspectorsOur ex MHRA inspectors provide expert GxP pharma compliance consulting services to the pharmaceutical, biotechnology and healthcare sectors.Pharma Compliance Consulting | Ex MHRA Inspectors Skip to content HomeAbout UsEventsSymposium 2024Meet Our ExpertsServicesProjects & Case StudiesCase Study 1: Inspection ReadinessCase Study 2: GMP ConsultancyCase Study 3: Facility Plan ReviewCase Study 4: Product Safety and Pharmacovigilance (PV) SystemCase Study 5: Corporate Audit Programme SupportCase Study 6: Mock EU GMP Inspection & RemediationMock Regulatory InspectionsGXP AuditsGXP Gap AssessmentsGXP Training and EducationGXP Remediation, Advice & SuportContract QP, RP, RPI and Compliance Monitor ServicesNewsNewsletter Sign UpEPiC Top TipsTestimonialsConsultation Meetings Contact Us +44 (0)1244 980544 enquiries@epic-auditors.com HomeAbout UsEventsSymposium 2024Meet Our ExpertsServicesProjects & Case StudiesCase Study 1: Inspection ReadinessCase Study 2: GMP ConsultancyCase Study 3: Facility Plan ReviewCase Study 4: Product Safety and Pharmacovigilance (PV) SystemCase Study 5: Corporate Audit Programme SupportCase Study 6: Mock EU GMP Inspection & RemediationMock Regulatory InspectionsGXP AuditsGXP Gap AssessmentsGXP Training and EducationGXP Remediation, Advice & SuportContract QP, RP, RPI and Compliance Monitor ServicesNewsNewsletter Sign UpEPiC Top TipsTestimonialsConsultation Meetings Contact Us +44 (0)1244 980544enquiries@epic-auditors.com Menu Expert Pharmaceutical ConsultancyExtensive Industry ExperienceContact UsWorld Class Compliance Supportex MHRA InspectorsMeet the ExpertsExpert ConsultantsFind the right consultant for your business.World Class Compliance SupportAdvice you can rely on.Extensive Industry ExperienceMany ex-regulatory inspectors.Our ServicesWe 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 InspectionsDrawing 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 AuditsWe 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 AssessmentsUnderstanding 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 EducationOur 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 & SuportWe 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 ServicesWe 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.Pharmaceutical Quality & Compliance SupportEPiC is a leading provider of expert GxP mock inspections, auditing, training, remediation and consultancy services to the global pharmaceutical industry, including pharmaceutical manufacturing services in hospitals.Since the company was formed in 2014, it has been our prime mission to improve and protect public health by providing the best quality GxP advice and support to the pharmaceutical industry using the best quality consultants.Get in Touch50 +Expert Consultants500 +Projects Completed25 +Former MHRA Inspectors10 +Years in business20 +Countries VisitedGxP SupportGMP, GLP, GDP, GCP, PVCase StudiesOur 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 ReadinessEPiC 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. Continue ReadingCase Study 2: GMP ConsultancyA 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.Continue ReadingCase Study 3: Facility Plan ReviewA 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.Continue ReadingTestimonialsSee what our clients say about us and our services.“Excellent symposium. Exceptionally knowledgeable presenters allowing an insight into the perspective of regulatory inspectors, this is invaluable information for those of us in industry. The platform was very impressive, and is easily the best example of an virtual meeting solution for large events I have encountered. Good breadth of topics covered across the day also, making it an excellent investment of time.”AttendeeGMP Symposium 2022“Excellent symposium – well paced, with expert speakers who could speak from experience on pertinent topics. Really enjoyed the day.”AttendeeGMP Symposium 2022“Really informative symposium with interesting contents and knowledgeable speakers. Highly satisfy.”AttendeeGMP Symposium 2022“The Self Inspection training course was very informative, presented well and offered many opportunities for interaction / questions. The material was fully relevant to the point and contained sufficient detail to understand the process and better prepare trainee’s to undertake self-inspections in the future. I found the trainers to be very knowledgeable and approachable. The course overall has been of great help to my role going forward and would highly recommend to other colleagues.”Delegate – March 2023Self Inspection Training“Very satisfied – It was very informative and was a comfortable forum to speak up about thoughts, principles and experiences. I found it reaffirming of my previous self-inspection knowledge and experiences.”AttendeeGMP Symposium 2022“The training session was practical with interactions with the trainers throughout. The structure of the course allowed for any questions to be asked at the time. All in all, a very enjoyable course.”AttendeeGMP Symposium 2022What do you require?How can we help your business? Our global GXP auditing and consultancy service can be tailored to meet client’s needs.Contact us to discuss your needs, ensure your compliance and ultimately safeguard patient safety.Contact UsExPharmaceutical Inspectors Consortium Limited T/A EPIC AuditorsRegistered Company No: 9231427 101 Galgate, Barnard Castle, Co Durham, DL12 8ES enquiries@epic-auditors.com +44 (0)1244 980544 LinkedIn CategoriesCategoriesSelect CategoryAnnex 1Autumn Compliance Seminar 2022AwardsCleanroomsClinical Trials RegulationCMTComplianceCompliance MonitoringConferencesCovid-19CPDCyber EssentialsDeficienciesEpic Auditors TeamEpic Management TeamEPiC Top TipsEPiC Virtual Symposium 2023EPiC’s Virtual Symposium 2024 Eventsex MHRA InspectorGCPGDMP Virtual Symposium 2023GDPGMDPGMPGMP Symposium 2022GXPIAGIMPIndustry UpdatesInspection ReadinessKnowledge ManagementLeadershipLegislationMaking PharmaceuticalsMHRANetworkingNew InspectorsNewsOutsources ActivitiesPQSQualified PersonsQuality AssuranceQuality ManagementQuality Risk ManagementRegulatory ComplianceRegulatory InspectorsRegulatory UpdatesRemote AuditsRoot Cause AnalysisSelf-InspectionShaping a Compliant FutureStandardsSterility AssuranceTestimonialsTraining MHRA Inspectorate BlogMHRA Good Clinical and Laboratory Practice Symposia (11 and 12 February 2025)10/01/2025Public Consultation on the International Council for Harmonisation ICH E6 (R3) Guideline for Good Clinical Practice Annex-215/11/2024DSUR Submissions and Fees are Changing from 1 June 202404/04/2024Pharmacovigilance unravelled: highlights of the 2024 MHRA GPvP Symposium04/04/2024Pilot GMP Single Inspection Program20/02/2024SearchSearchSearchCyber EssentialsCopyright © 2025 EPiC Auditors. 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