ISO 27001 and Data Integrity: Information Security Risks in a GxP Environment
Information security has quietly become a GMP concern. As pharmaceutical operations move to cloud platforms, connected instruments and AI-assisted systems, the confidentiality and integrity of[…]
The EU Medical Technology Framework: A Compliance Roadmap for 2026 and Beyond
The European Union’s medical technology rulebook — the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) — is the most demanding device[…]
Biosimilars in Europe: Interchangeability and the New Tailored Clinical Approach
By 2026 the European biosimilar framework has matured from cautious, case-by-case review into one of the most confident regulatory systems in the world — and[…]