Pharmaceutical Compliance
You Can Rely On
Expert QP, RP, and RPi services. Inspection readiness and GxP auditing for manufacturers, importers, and wholesalers across the United Kingdom and European Union.
Regulatory Expertise.
Real-World Experience.
gxpclinic was founded by Dr. Raffaele Misul to give pharmaceutical businesses access to senior-level regulatory expertise without the overhead of a full-time headcount.
Bridging Compliance and Innovation
With roots in large pharma and specialist contract organisations, Dr. Misul has held QP, RP, and Head of Quality positions across oral solid dosage, biologics, ATMP, and sterile product manufacturing. He understands what regulators look for because he has sat in both chairs.
For over three decades, gxpclinic has served clients navigating the unique dual-framework reality of post-Brexit pharmaceutical regulation.
- 30+ years in pharmaceutical quality and regulatory affairs
- Qualified Person registered with MHRA and EU national authorities
- Expert in GMP, GDP, and pharmaceutical quality systems
- Extensive experience with MHRA, EMA, and competent authority inspections
- Advisor to pharmaceutical manufacturers, importers, and wholesalers
Dr. Raffaele Misul
Founder, CEO & Principal Consultant at gxpclinic. A seasoned pharmaceutical professional with a PhD in Pharmaceutical Sciences and over 30 years of hands-on industry experience.
From batch certification to full QMS overhauls, Dr. Misul has guided companies through the most challenging regulatory landscapes with a 100% inspection success rate.
Expert Services for a
Regulated Industry
From QP batch release to full inspection preparation, we provide the regulatory expertise pharmaceutical companies need to stay compliant and competitive.
Qualified Person (QP) Services
Contractual QP services for manufacturers, importers, and MAH holders. We handle batch certification, QP declarations, and Annex 16 responsibilities.
- Batch certification and release under UK & EU GMP
- Annex 16 QP declarations for imported medicinal products
- QP oversight of contract manufacturing organisations (CMOs)
- Site readiness for MIA and MIA(IMP) licensing
- QP gap analysis and remediation plans
Responsible Person (RP) for Wholesalers
Named and deputy RP services for wholesale dealers holding or applying for WDA(H) licences, ensuring full compliance with MHRA expectations and EU GDP.
- Named RP and deputy RP appointments
- WDA(H) licence applications and variations
- GDP SOP development and annual review
- Supplier and customer qualification programmes
- Temperature excursion management and recalls
Responsible Person (Import) — RPi
A role unique to post-Brexit UK. As your RPi, we take formal responsibility for verifying that imported finished products meet UK GMP requirements before release.
- RPi designation under UK MIA licence conditions
- Post-Brexit import testing waiver applications
- Supply chain verification from EU and third countries
- GMDP certificate verification and site qualification
- MIA(IMP) variation and renewal support
Inspection Readiness & Auditing
Comprehensive preparation for regulatory inspections from MHRA, EMA, and EU national competent authorities. Mock inspections, gap analysis, and CAPA.
- Mock MHRA and competent authority inspections
- Pre-inspection gap analysis against current GMP/GDP guidelines
- CAPA management and verification of effectiveness
- First-, second-, and third-party GxP audits
- Annual product review (APR) and quality metrics support
Quality Management Systems
Design, implementation, and maintenance of pharmaceutical quality systems aligned with ICH Q10. Practical, inspection-ready documentation.
- QMS design and SOP authoring aligned to ICH Q10
- Change control, deviation, and CAPA systems
- Validation master plans and CSV/CSA programmes
- Training programmes and qualification frameworks
- Self-inspection programme development and execution
Regulatory Strategy & Advisory
Strategic guidance for pharmaceutical companies navigating UK and EU regulatory complexity post-Brexit, through product launches and site transfers.
- Post-Brexit regulatory strategy for UK vs EU divergence
- Licence applications, variations, and renewals
- Technical due diligence for M&A and site acquisitions
- Regulatory intelligence and horizon scanning
- Expert witness and dispute support services
GxP Training
Bespoke training programmes for staff at all levels. From induction to advanced GMP/GDP modules, delivered on-site or remotely.
Regulatory Affairs
Strategic regulatory support for MA applications, variations, renewals, and post-authorisation commitments across the UK and EU.
Risk Assessment & FMEA
Systematic risk assessment for pharmaceutical operations. FMEA, risk-based decision making, and quality risk management aligned with ICH Q9 principles.
Commercial Brand & Generic Pharma
End-to-end regulatory support for commercial pharmaceutical products. Batch release, market authorisation maintenance, and lifecycle management for branded and generic medicines.
IMP & NPP Services
Specialised QP and regulatory support for Investigational Medicinal Products and Named Patient Programmes. MIA(IMP) compliance, importation, and clinical trial supply chain oversight.
View Published Paper →From First Call to
Ongoing Partnership
A structured, efficient engagement model built around your timelines and regulatory obligations.
Initial Scoping Call
Free 30-minute call to understand your compliance requirements, timelines, and the specific regulatory context — UK, EU, or both.
Proposal & Agreement
Tailored proposal with clear scope, deliverables, and fees. Service agreements drafted to reflect your specific licence and operational model.
Onboarding & Gap Analysis
Structured review of your current quality system, documentation, and compliance posture. Gap analysis report with prioritised action plan.
Active Compliance Support
Ongoing QP, RP, or RPi services with defined SLAs. Monthly reporting, CAPA tracking, and direct availability for urgent regulatory matters.
UK & EU. Two Frameworks.
One Team.
Post-Brexit pharmaceutical regulation means operating under two distinct legal frameworks simultaneously. Our consultants hold credentials and practical experience in both — no handoffs, no gaps.
We provide seamless regulatory coverage across the United Kingdom, European Union, and third-country supply chains.
Your Next Inspection
Should Not Be a Surprise
Whether you need an experienced QP tomorrow or want to build long-term compliance infrastructure, we are ready to support you. First consultation is always free.
Let's Talk Compliance
Whether you have an urgent regulatory matter or are planning ahead, we respond to all enquiries within one business day.
Contact Information
Our London office serves as the hub for our UK and European operations. We are available for on-site engagements across the continent.