EPE European Pharma ExpertsComply · Register · Grow
EU Pharma · Quality · Regulatory · Validation

European expertise. Global pharmaceutical compliance.

Practical consulting, regulatory support, validation, training and licensing for pharmaceutical companies operating across the EU, UK, MENA and international markets.

Discuss your project Explore our services
GMPGDPGLPGCPCTD/eCTDValidationLicensing
IndependentSenior expert advice
PracticalAudit-ready deliverables
InternationalEU · UK · MENA · Global
LifecycleDevelopment to market
We work to
  • EU GMP
  • EMA
  • ICH
  • GAMP 5
  • Annex 1
  • Annex 11
  • 21 CFR Part 11
  • eCTD
  • GDP
  • GVP
  • ISO 9001
How we help

Integrated pharmaceutical consulting services.

One expert network supporting quality, regulatory, validation, technical operations and commercial expansion — from a single audit to a full local presence.

S/01

GxP & Quality Compliance

EU GMP, PQS/QMS, SOPs, deviations, CAPA, change control, OOS/OOT, QRM, supplier qualification and data integrity.

Request support →
S/02

Regulatory Affairs & CTD

EU strategy, MAA pathways, CTD/eCTD review and preparation, CMC, variations, renewals and authority responses.

Review my dossier →
S/03

Validation & Qualification

VMP, URS, DQ/IQ/OQ/PQ, process and packaging validation, hold-time studies and lifecycle validation.

Plan validation →
S/04

Cleaning Validation & HBEL

PDE/ADE/HBEL strategy, MACO, worst-case selection, sampling, recovery and legacy remediation.

Assess my program →
S/05

Audits & Inspection Readiness

GMP/GDP audits, mock inspections, supplier and CMO audits, pre-inspection readiness and remediation.

Prepare for inspection →
S/06

Digital GxP & Data Integrity

CSV/CSA, GAMP 5, Annex 11, 21 CFR Part 11, LIMS/MES/eQMS validation, audit trails and ALCOA+.

Assess digital compliance →
S/07

Pharmaceutical Development

Formulation strategy, generic development, technology transfer, scale-up, stability and CMO/CDMO selection.

Discuss development →
S/08

Licensing & Market Access

In-licensing, out-licensing, product sourcing, partner search, due diligence and EU–MENA market entry.

Explore an opportunity →
S/09

Laboratory Excellence

QC systems, analytical validation and transfer, stability, instrument qualification and OOS/OOT.

Explore service →
S/10

Facilities, Engineering & CQV

GMP facility design review, cleanrooms, HVAC, utilities, flows, commissioning and qualification.

Explore service →
S/11

Pharmacovigilance

PV systems, PSMF/QPPV support, signal management, aggregate reports, audits and inspection readiness.

Explore service →
S/12

Interim Experts

Experienced QA, validation, regulatory and GMP resources for temporary leadership and execution.

Explore service →
Start with the problem

Facing a compliance or regulatory challenge?

Preparing for a GMP inspection
Cleaning validation no longer compliant
CTD dossier needs expert review
Need an EU regulatory pathway
Critical audit findings to remediate
Qualifying a new manufacturing site
Looking for a licensing partner
Urgent authority-response support
EPE Rapid Response

Urgent pharmaceutical compliance support when time matters.

For upcoming inspections, critical GMP observations, authority deficiencies, major deviations, data-integrity findings, supplier failures and dossier issues.

Request urgent support
How it works

A single partner across the product lifecycle.

Most clients start at one stage and stay for the rest. The order is a real sequence — each stage sets up the next.

01 / Comply

GxP & quality systems

Audits, gap analysis and quality-system remediation against EU GMP, GDP and data-integrity expectations.

02 / Validate

Qualification & validation

Process, cleaning, computerized-system and facility validation across the full lifecycle.

03 / Register

Regulatory & CTD

EU strategy, CTD/eCTD preparation, MAA pathways, variations and authority responses.

04 / Grow

Licensing & access

In- and out-licensing, partner search and market entry across EU, UK and MENA.

European Pharma Experts Academy

Training built for real pharmaceutical operations.

Live online, on-site and customized corporate programs designed around practical GxP implementation, inspection expectations and risk-based decision-making — delivered by the same senior experts who run our projects.

Live onlineOn-siteIn-house / corporateWorkshopsCertificates of attendance
7
Specialist tracks
40+
Named courses
100+
Courses in development

Every course can be tailored to your products, processes and current findings — and mapped to specific roles across QA, Production, QC, Engineering, RA and Warehouse.

GMP & Quality Systems

T/01

Core good-manufacturing-practice knowledge and a working quality system that survives inspection.

  • EU GMP Fundamentals2 days · all roles
  • Advanced EU GMP for Manufacturing2 days · QA / Production
  • Good Documentation Practices (GDocP)1 day
  • Deviations, CAPA & Root-Cause Analysis2 days
  • Change Control Management1 day
  • OOS / OOT Investigations1 day · QC
  • Quality Risk Management (ICH Q9)1 day
  • Pharmaceutical Quality Systems (ICH Q10)1 day

Validation & Qualification

T/02

From master planning to lifecycle validation of equipment, processes and analytical methods.

  • Validation Master Plan (VMP) Essentials1 day
  • Equipment Qualification: DQ/IQ/OQ/PQ2 days
  • Process Validation Lifecycle (Stages 1–3)2 days
  • Analytical Method Validation (ICH Q2)2 days · QC
  • Analytical Method Transfer1 day
  • Sterile & Aseptic Process Validation2 days
  • Hold-Time & Stability Study Design1 day

Cleaning Validation & HBEL

T/03

Toxicology-based cleaning limits, worst-case rationale and remediation of legacy programs.

  • Cleaning Validation Fundamentals2 days
  • HBEL, PDE & ADE Determination1 day
  • MACO & Worst-Case Selection1 day
  • Sampling, Recovery & Analytical Methods1 day
  • Cleaning Validation Lifecycle & Monitoring1 day
  • Legacy Program Remediation Workshop1 day

Regulatory Affairs & CTD

T/04

Building and maintaining dossiers that pass technical validation and authority review.

  • CTD & eCTD Dossier Preparation2 days
  • CTD Module 3 (Quality) Deep Dive2 days
  • EU Marketing Authorisation Pathways1 day
  • Variations & Lifecycle Management1 day
  • CMC Regulatory Strategy1 day
  • Responding to Authority Deficiencies1 day

Digital GxP & Data Integrity

T/05

Computerized-system validation and data governance to current ALCOA+ expectations.

  • Data Integrity & ALCOA+ Principles1 day · all roles
  • Computerized System Validation (CSV/CSA)2 days
  • GAMP 5 (2nd Edition) in Practice1 day
  • Annex 11 & 21 CFR Part 11 Compliance1 day
  • Audit Trail Review in Practice1 day · QA / QC
  • Validating LIMS / MES / eQMS1 day

Audits & Inspection Readiness

T/06

Preparing sites, teams and suppliers to face inspectors calmly and pass.

  • Preparing for an EU GMP Inspection1 day
  • Mock Inspection Workshop2 days · on-site
  • Internal / Self-Inspection Auditor Training2 days
  • Supplier & CMO Auditing2 days
  • Hosting Inspectors & Managing Findings1 day
  • Annex 1 & Contamination Control Strategy1 day

GDP, PV & Distribution

T/07

Distribution, responsible-person duties and pharmacovigilance across the supply chain.

  • Good Distribution Practice (GDP)1 day
  • Responsible Person (RP) Training2 days
  • Cold Chain & Temperature Management1 day
  • Pharmacovigilance System & PSMF1 day
  • QPPV Responsibilities & Oversight1 day
  • Signal Management & Aggregate Reporting1 day

Corporate & Custom Programs

T/08

Tailored curricula for whole sites and teams, built around your products and findings.

  • New-Hire GxP Onboarding Programmodular
  • Role-Based GMP Refresher Seriesannual
  • Post-Inspection Remediation Trainingon demand
  • Train-the-Trainer for Internal QA2 days
  • Site-Specific Data Integrity Culturecustom
  • Executive Briefings for Management½ day
Request the full course catalogue Book in-house training

Durations are indicative · all courses available as tailored in-house sessions · certificates of attendance issued

Industries

Built for regulated life-science operations.

Human Pharmaceuticals
API Manufacturers
Biotechnology
CMO / CDMO
Contract Laboratories
Importers & Distributors
Start-ups
Food Supplements
EPE Expert Network

The right expertise for each assignment.

European Pharma Experts is structured as an independent expert network, giving clients targeted support across quality, regulatory, validation, technical operations and business development.

Quality & GMPRegulatory AffairsQualified Person SupportValidationToxicology / HBELAuditingCMC & DevelopmentEngineeringLicensing & BDPharmacovigilance
Knowledge center

Technical insight for regulated pharmaceutical teams.

Authoritative, practical content — built to inform your teams and attract the right enquiries.

Cleaning Validation

PDE vs ADE vs HBEL vs MACO

What each concept means and how it drives cleaning limits.

Regulatory Affairs

CTD Module 3: a practical review guide

Common quality gaps that delay regulatory submissions.

GMP

How to prepare for an EU GMP inspection

A practical readiness framework for manufacturing sites.

About EPE

Independent expertise. Practical execution.

European Pharma Experts supports pharmaceutical companies with complex compliance, regulatory, validation and commercialization challenges. Our approach is risk-based, evidence-driven and focused on deliverables that work in real operations.

We bridge European regulatory expectations with the practical needs of manufacturers, developers, licensors, distributors and investors operating across international markets.

Ask an expert

Tell us what you need help with.

Share your challenge, market and timeline. EPE will route your enquiry to the appropriate expert.

Confidential · Independent · Expert-led
Webeuropeanpharmaexperts.com
MarketsEU · UK · MENA · International