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

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

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

Ask us anything.
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We will be more than happy to help you find the most suitable solution for your business.