January 14, 2025
Guideline for Good Clinical Practice ICH E6 (R3)
The ICH E6 (R3) Guideline reached Step 4 of the ICH process on 06-Jan-2025. This marks a major milestone in...
News & Events
All news & events
January 14, 2025
FDA Draft Guidance Protocol Deviations for Clinical Investigations
In December 2024, the FDA published a draft guidance titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and...
January 7, 2025
FDA Issues Draft Guidance on AI Use in Regulatory Decision-Making
Yesterday 6th January 2025, the U.S. Food and Drug Administration (FDA) released a draft guidance titled “Considerations for the Use...
November 15, 2024
ICH E6(R3) Annex 2 Open for Public Consultation: A Step Forward in Clinical Practice Standards
The International Council for Harmonization (ICH) is inviting stakeholders to participate in the consultation for Annex 2 of the ICH...
November 3, 2024
Join Us at the 2024 International QA Conference in Brighton!
We’re excited to announce our participation in the 2024 International QA Conference in Brighton from November 6-8! Join us as...
October 2, 2024
Advancing Quality: Join Us at the XXVII SEGCIB Conference!
We are pleased to attend the XXVII Conference of the Spanish Society for Quality Assurance in Research (SEGCIB) on November...