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Learn when medical software qualifies as a medical device under EU MDR & IVDR regulations. Explore classification rules, examples, and compliance tips for manufacturers.

Explore case study showing the development of a project for a new pharmaceutical manufacturing plant with the objective to fulfill GMP requirements and minimise risks of contamination as well as meeting the current qualification and validation standards.

Learn how to navigate DMF submission in China with Rephine’s expert guidance. From compliance reviews to NMPA approval — streamline your entry into the Chinese pharmaceutical market.

The Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation (AIQSV) is an essential resource for pharmaceutical laboratories striving to meet stringent regulatory standards.

In today’s fast-evolving regulatory landscape, maintaining compliance with Computer System Validation (CSV) and Data Integrity standards is more critical than ever. Organisations across the pharmaceutical, biotech, and medtech industries often face significant challenges when it comes to ensuring their systems and processes are compliant and audit-ready.

Our guide simplifies GSPR compliance, helping medical device companies meet EU safety standards, streamline CE marking, and get market-ready faster.