Life Sciences 

With the layers of regulations, it is easy to become overwhelmed by life science compliance requirements. However, your organization’s efficiency and time to market depend upon the ability to prioritize essential validation and qualification requirements over less critical activities. GxP-CC delivers this critical insight, helping leading life sciences organizations around the globe to streamline compliance and strengthen operational efficiency.  

We partner with life science companies at every phase of product development, supporting the full lifecycle of computerized systems. With the support of our experts’ extensive experience in the industries they now serve, we are able to tailor solutions that achieve organizations’ unique challenges. We deliver solutions that strengthen organizational standards with industry best practices to streamline processes, provide more valuable insight, reduce risk, and simplify compliance.

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Blog
From Medical Devices to Drug Development: Advancing Responsible AI in Healthcare
Blog
FDA/EMA AI Principles: Role-Based Roadmap for Regulated Pharma Companies
Blog
ISO27001 ≠ Annex 11: A Costly Misunderstanding in GMP Systems
Webinar
Live Webinar Series | Applying EU GMP Chapter 4, Annex 11 & Annex 22
Blog
Implementing AI in GMP: Key Takeaways from the EU’s Annex 22 Guideline
Blog
Think Beyond the Device – The New Age of Analytical Qualification
Blog
EU-GMP Chapter 4 Revision: Anticipated Changes in Documentation and Data Governance
Webinar
GxP-Hybrid Project Management – Implementing Predictive Testing in a GxP Environment within Agile
Flyer
Helping You Navigate Compliance with Confidence
Flyer
Unlock AI/ML Compliance Confidence
Webinar
ANNEX 22 Update: A Deep Dive into the EU’s New Annex 22 on Artificial Intelligence
Webinar
Annex 11 Update: What the 2025 Draft Means for Your GxP Systems
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