This guide was drafted by a multidisciplinary working group under the overall co-ordination of the Committee of Experts on Quality and Safety Standards in Pharmaceutical Practices and Pharmaceutical Care (CD-P-PH/PC). It provides: ✅ Structured recommendations...

ICH HARMONISED GUIDELINE: The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality SCOPE AND ORGANISATION The M4Q(R2) guideline establishes the location and structure of quality information for registration applications of all...

Release notes: https://lnkd.in/dmRB2inn User Manuals. Legacy devices: https://lnkd.in/d5cjaMgz Regulation devices: https://lnkd.in/dGSwt9rp

EU & US Regulatory News (AI in Drug Development – Guiding Principles) The European Medicines Agency (EMA), in collaboration with the U.S. Food and Drug Administration (FDA, has published Guiding Principles of Good AI Practice in Drug Development (January 2026)....