September 25, 2025
FDA Final Guidance on Computer Software Assurance Released
On 24th Sept 2025, the FDA published its final guidance on Computer Software Assurance (CSA) for production and quality system...
News & Events
All news & events
January 28, 2025
ICH E6(R3) Step 5 Adoption Announced by EMA
The European Medicines Agency (EMA) has announced the adoption of the ICH E6(R3) Guideline for Good Clinical Practice (GCP) at...
January 27, 2025
Pharmity & Qlarix at Farmaforum 2025: Don’t Miss the Clinical Research Forum!
Join us on 17-18 September 2025, in Madrid for the Farmaforum – Clinical Research Forum. Discover key insights into the...
January 27, 2025
Training Material on ICH GCP E6 (R3)
Looking for must-read training material on ICH GCP E6(R3)? Check out the Step 4 presentation published by ICH GCP –...
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...
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FDA Draft Guidance Protocol Deviations for Clinical Investigations
In December 2024, the FDA published a draft guidance titled “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and...