Quality Compliance

Inspection readiness?

Discover our tailored, cost-effective and AI-driven programs for Quality Management.

Are you 100% compliant?

Lack of inspection readiness or failed attempts at post inspection remediations may lead to huge operating and legal costs like warning letters, product recalls, withdrawals and sanctions.

Don’t risk losing quality and trust: choose the right training, guidance and support.

Prepare for FDA and other authorities’ inspections
Review documentation and records
Identify gaps and take remedial actions
Execute mock inspections and CAPA
Achieve total control over production and processes
Benefit from outsourced Quality Management System support
Enhance resources’ competences and behavior

GxP Compliance Support

GMP | GDP Services

Inspection Readiness Programs
Post Inspection Support
Complex CAPA/Remediation plan management execution
QMS Implementation & Optimization
Continuous improvement and KPI/Quality Metrics Implementation
Sterility Assurance
Technology Transfer
Validation Support (analytical, cleaning, process)
Auditing & Due Diligence
Critical Events Management (deviations, complaints, OOS, Recalls, Stability)
Risk Management Implementation
Historical Data Review of Laboratory and Production Data
Supplier Management & Monitoring Strategies
Training
CAPA System Implementation
Change Control System Implementation
Capacity & Skills Assessment
Improving Quality & Reducing Defects – Six Sigma

GCP Services (Clinical Trials)

Auditing
SOPs/Policies Development (issuing, review)
GCP Review of Study Protocol, Informed Consent Form, CRF, Investigator Brochure and Clinical Study Report
TMF | ISF Review & Quality Check
Quality System GAP Analysis vs regulations
Data Integrity & Compliance Assessments
Clinical Process Mapping
CSV, Data Migration Plan & Data Quality Control
Inspection Readiness
CAPA Definition and Implementation
Archiving Requirements for Study Documents
Due Diligence
Clinical Study Set Up
QA Services & Training
Compliance verification for clinical sites involved in Bioequivalence Studies
Risk Analysis for Clinical Audit Planning
Risk Analysis model definition for clinical trials
Vendors | CROs selection

GLP Services

Facility Assessment & Audit
GLP Remediation Plan & Execution
Documentation Redaction Support
GLP Study Monitor
Study Audit
GLP QA Support
GLP Training
First Certification Support

GVP Services

Auditing
Inspection Readiness
PV Quality Assurance and EU-QPPV Outsoutcing
Policies/Manuals/SOP/WI development, issuing, review
Risk analysis for strategic and tactical audit planning
PV Documents preparation and review
Pharmacovigilance Processes Mapping
GAP Analysis
Remote Data Entry/QC Support into Safety Database

Quality Management Systems (QMS)

Strengthen your quality management with expert QMS implementation and optimization tailored to industry standards.

Gap Assessment
Remediation Planning and Execution
SOP and Quality Document Development
QMS Digitalization and System Support
Training and Cultural Development
Audit Readiness and Support
Supplier Qualification Programs
KPI Monitoring and Management Review

MHRA Top Findings Report

Keep up with regulatory trends with a comprehensive analysis of the most common inspection findings regarding EU Regulations for 2018 and 2019.

In this report you’ll find data, charts, comparisons and comments made by our top experts.

Pharmacovigilance support

PQE can support you everywhere in the world with a high-level quality service coordinated by our central centre of excellence.

Sterility Assurance Coaching Services

Advance your Sterility Assurance team’s expertise and ensure top-quality sterile manufacturing with PQE Group’s specialized coaching.

Tailored training sessions on regulatory standards, quality aspects, and international guidelines
Support for Design, Issue, and Revision of Key Sterility Assurance Documentation
Holistic roundtables to improve your team’s planning & design strategies for process control and contamination risk
Focused expertise and support to address backlogs, review documentation, and implement solutions

Cleaning Validation Services

Ensure full compliance with industry standards and regulatory requirements through PQE Group’s expert cleaning validation services.

Gap Assessment
Remediation Plan
Development of Cleaning Procedures
Cleaning Validation SOP and Master Plan
Cleaning Validation Strategy
Acceptance Limits Calculation
Analytical and Sampling Method Development
Critical Sampling Point Selection
Continuous Verification Strategy
Project Management
Hands-On Support

Process Validation Services

Validate your process with confidence: GMP-compliant, risk-based, and fully traceable.

Gap Assessment
Remediation Plan
Equipment Selection (FAT/SAT incl.) and Qualification (IQ/OQ/PQ)
Process Development (Phase 1)
Process Validation (Phase 2 – PPQ)
Continuous Process Verification (Phase 3 – CPV)
Project Management

Medical Device Compliance Support

21 CFR 820 Compliance
ISO 13485 Compliance
MDSAP Compliance & Validation Support
Mock Inspections
Notified Body Audits & FDA Inspections Support
R&D Support
DHF, DMR, DHR Creation and Review
Quality Policies, Manuals SOPs
Documentation Management
CAPA & Complaints Management
Vigilance & MDR System Implementation
Risk Management, Usability Support
MD Software Life Cycle Validation
MDDR & IVDR Requirements
PMS, PMCF & Clinical Evaluation

Assess and evaluate risks

A number of hidden potential violations may already
be embedded in your current processes.

Achieve growth and successs

Prevent impacts on business operations
by ensuring that all data is compliant.

Ask us anything.

Being non-compliant is a risk no company can afford, especially in such a highly regulated environment like Lifesciences.

Quality Compliance

Are you 100% compliant?