Quality
Compliance

For Life Science businesses in highly regulated environments, compliance is not an option. Prepare to successfully pass inspections and design post-inspections remediation plans to achieve and maintain approval for your product with PQE Group's tailored and cost-effective programs for Quality Management.

Discover our solutions

Pharma Compliance

Align to GxP standards and learn how to efficiently conduct pharmacovigilance and clinical trials.

MD Compliance

Conform to Life Science Quality guidelines and deploy an effective strategy for Medical Device Vigilance.

Trainings

Provide the correct training on policies, procedures, documentations and behavior to your resources.

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, EMA 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 Assurance support
  • Enhance resources’ competences and behavior

Focus on: Annex 1

With the release of the Second Issue of 2020 GMP Annex I, the standard for all sterile manufacturers has been widely extended and revised.

PQE Group has collected all the informations you need to comply in an exhaustive guide. Don’t wait: request the download now for free and get all the insights on sterile assurance.

Pharma Compliance Portfolio

Pharma Compliance Full Service Portfolio

  • Compliance Strategies
  • Continuous Improvement and Performance Metrics Implementation
  • Risk Management Implementation
  • Quality System Implementation (Corporate Policies and Local SOPs)
  • Quality Structures (QC, QA, RA) Assessments for Skills and Staffing
  • Inspection Readiness Master Plans (FDA, EU, ANVISA, CFDA, PMDA, TGA, COFEPRIS and other regulatory bodies)
  • Mock Inspections and Assistance During Inspections/Post-Inspection
  • Supplier Management and Monitoring Strategies
  • Training Systems Implementation / Mentoring / Coaching
  • Retrospective Review of Production Data
  • Training in GMP/GDP Compliance and Topical Matters
  • Support in critical event management (complaints, deviations, sterility failures, recalls)
  • Pharma Organizational Change Management Support
  • CAPA System Implementation
  • Annual Product Review support
  • Sterility Assurance
  • Improving Quality and reducing defects – Six-Sigma
  • Auditing service (e.g. Initial, Follow-up, For Cause… i.e. CROs qualification, Investigational Sites, Centralized Laboratories)
  • SOPs/Policies Development, Issuing and Review
  • Study Protocol, ICF, IB and other Essential Documents Review
  • TMF and ISF review and quality check
  • GAP analysis of the quality System vs new EU-CT regulation and ICH E6 R2
  • Data Integrity and Compliance Assessments
  • Clinical Process mapping
  • Training (From basic GCP to advanced specific trainings)
  • E-Learning content development
  • Training on the job (i.e. Audit with Junior Auditors and CRA)
  • Computer System Validation (i.e. eCRF, eSD, eTMF, Patient Database, IV/WRS…), Data Migration plan and Data Quality Control
  • Inspection Readiness and Support (Sponsor, CRO, Investigational Site, Back & War Room)
  • CAPA definition and implementation
  • Archiving Requirements for Study Documents
  • Bioequivalence Study Design
  • Clinical Study Setup
  • QA Services & Training
  • Compliance Verification with minimal technical requirements for clinical sites involved in Bioequivalence studies (Determina AIFA n.809-2015)
  • Risk Management
  • Vendors – CRO Selection
  • Auditing service (qualification of suppliers and over-sight on MAHs, Affiliates and specific audit to data and/or documents, internal Audit)
  • PV Quality Assurance Outsourcing and EU-QPPV Outsourcing
  • SOPs/Policies Development Issuing and Review
  • CAPA definition and implementation
  • PSMF, SDEA, PSUR, DSUR, Paper Based Audit and other PV documents review
  • Data Integrity and Compliance Assessments
  • Pharmacovigilance Processes Mapping
  • E-Learning Content development
  • Gap Analysis of the Quality System vs EU GVP
  • Computer System Validation (i.e. Argus Safety, ArisG AERS, PcV Manager, SafetyDrug, in-house and on-demand versions) Data Migration plan and Data Quality Control
  • Remote Data Entry support
  • Risk Management Plan review

Focus on: Front-end back-end service model

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

When on-site audits and mockup inspections are not practical or hindered by geopolitical or health circumstances, choose PQE Group’s flexible delivery models.
Read more about this topic in our case studies:

Medical Device Compliance Portfolio

MD Compliance Full Service Portfolio

  • 21 CFR 820 compliance
  • ISO 13485 compliance
  • MDSAP Compliance & Validation Support
  • Notified Bodies Audits & FDA Inspections Support
  • Mock Inspections
  • DHF, DMR, DHR creation and review
  • Quality Policies & Manual, Standard Operating Procedures
  • Documentation Management
  • CAPA and Complaints management system implementation
  • Vigilance and MDR system implementation
  • Risk Management, Usability Support
  • MD Software Life validation
  • Auditing service (qualification of suppliers and specific audit to data and/or documents – Follow-up, For Cause… i.e. CROs, Investigational Sites, Centralized Laboratories)
  • SOPs/Policies Development, Issuing and Review
  • Process Mapping
  • Trainings
  • Data management
  • Quality management
  • Clinical evaluation management
  • ISO 14155 compliance
  • CER preparation
  • Auditing service (suppliers qualification and over-sight, specific audit to data and/or documents)
  • Quality Management and SOPsMD Vigilance

Want to know more?

Risk Evaluation for Nitrosamines

Read our article on the raising risk awareness on Nitrosamine impurities.

On-Demand Webinar

Browse our Knowledge Gallery and view our free webinars on Compliance.

Medical Cannabis Solutions

Learn how to update your processes and assure the quality of your product.

Why PQE?

Featuring combined local teams of senior experts and former agency inspectors, available on the shortest notice, PQE Group has the in-depth knowledge of Quality and Manufacturing processes to deliver tailored and sustainable Compliance Management solutions in your language.

Trainings

Trainings Portfolio

  • Computer System Validation (GAMP, 21CFR Part 11, IT Infrastructure)
  • FDA Inspection Readiness
  • Quality Management System
  • Process Equipment, Laboratory Equipment & Utilities Qualification
  • Process Validation
  • Analytical Methods Validation
  • Regulatory Affairs
  • Risk management
  • Systems Implementation, Mentoring & Coaching
  • GMP/GDP Compliance & Topical Matters
  • GCP Compliance & Clinical Trials
  • Process Analytical Technology
  • Technology Transfer
  • Pharmacovigilance Compliance & PV Operations
  • Computer System Validation (GAMP, 21CFR Part 11, IT infrastructure)
  • ISO 13485 compliance
  • New MDR 2017/745, 2017/746
  • MDSAP Model
  • FDA Inspection Readiness
  • Design control & Change
  • Medical Device Reporting
  • CAPA & Complaints Management
  • Quality Management System
  • Process Equipment Qualification
  • Laboratory Equipment Qualification
  • Process Validation
  • Analytical Methods Validation
  • Medical Device Directives
  • Regulatory Affairs
  • Risk Management
  • ISO14155 Compliance and clinical evaluation
  • Technology Transfer
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