Quality Compliance

Inspection readiness?

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

Quality Compliance

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.

GxP Compliance Support

  • 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

  • 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

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

  • 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

Front End – Back End Service Model

Thanks to its global and multicultural assets, PQE Group can easily and steadily deliver its turn-key solutions and services remotely, with our front-end plus back-end strategy.

When on-site audits and mockup inspections are not practical or are hindered by geopolitical or health circumstances, choose PQE Group’s flexible delivery models.

MD 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.

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Ask us anything.

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