30 September, 2025
AI in Compliance: What ISO 42001 and EudraLex Annex 22 Mean for Life Sciences
As Artificial Intelligence (AI) moves from experimental use to operational reality in life sciences, regulatory frameworks are catching up. Two major documents are now leading the way in shaping responsible, auditable AI use in both regulated and non-regulated environments:
3 September, 2025
Turning Deviations and CAPA Into Opportunities for Improvement
In the life sciences sector, quality is not just a regulatory requirement, it is the foundation of trust. Every deviation, non-conformity, or ineffective CAPA plan has the potential to create ripple effects: reputational damage, recurring quality issues, operational inefficiencies, data integrity concerns, or even regulatory findings such as FDA 483s.
2 July, 2025
Our new solution for our Medical Devices clients: V&V Strategy Assessment
At GXP CONSULTING, we’re excited to introduce a new service tailored to one of the critical stages of medical device development: Verification & Validation (V&V).
19 June, 2025
Quick Impact Assessment – Project Plan Review for MedTech industries
We are pleased to announce the launch of a new high-value support format designed specifically for MedTech companies: the Quick Impact Assessment – Project Plan Review.
