Latest Insights

Regulatory Affairs

IVDR: What Does It Mean for Manufacturers of In Vitro Diagnostic Devices?

The transition to IVDR introduces new challenges for IVD manufacturers, with stricter requirements and revised timelines to ensure compliance

CSV & Data Integrity

Mastering PI System Validation: A 'Glocal' Strategy for Success

Discover PQE’s 'Glocal' validation approach: a balanced strategy combining global standards with local customization to optimize time, cost, and.

GxP Compliance

Sterile Aseptic Processing – Stepping into the Future

Discover the limitations of RABS vs. isolators and why transitioning to isolator systems is essential for meeting evolving sterile processing GMP.

Medical Cannabis

What conditions are most commonly treated with medical cannabis?

Medical cannabis is commonly used for pain management, oncological symptoms, anxiety and neurodegenerative diseases.

Pharmacovigilance

2023 PhV IWG Annual Report: Key Changes

Discover key changes in EU PHV for 2023, including stricter regulations, digital tools, and compliance updates for human and veterinary medicine.

CSV & Data Integrity

Mastering Computerised System Validation: An In-Depth Review of EU GMP Annex 11

Discover how the increased use of computerized systems and new technologies like AI and Machine Learning are reshaping Computerized System Validation.

Medical Cannabis

Safety Risks in Unregulated Cannabis Production

Explore the health risks of contaminated cannabis and the need for strict quality controls to ensure consumer safety.

Medical Cannabis

How many medical cannabis patients do you have to manage in terms of numbers and how many of their needs can you satisfy?

Our team works closely with doctors and engages with patients daily, offering guidance on therapy use and managing drug interactions

Regulatory Affairs

Medicines in Europe: Registration, lifecycle Management and Extension

Medicines in Europe need Marketing Authorization and ongoing safety monitoring to ensure compliance and patient safety.

Medical Cannabis

Seed to Solution: Our engineering approach for your cannabis project

From facility design to regulatory compliance, PQE Group delivers expert solutions for medical cannabis projects. Optimize operations and reduce costs