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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Are You Confident in Your Training Records? Auditors Will Be.
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EMA releases concept paper to revise GMP Guidelines for ATMPs
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GxP Audit Trail Review | Stay Compliant with FDA & Annex 11
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Data Integrity in the Personalized Medicine Journey
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EU GMP Annex 11: Core Requirements & Upcoming Revision
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Personalized mRNA Cancer Immunotherapies: New Guidelines, Big Possibilities
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How Compliance-Minded Is Your Organization?
Webinar
Webinar – Audit Trail and Audit Trail Review in GMP – Trends, Guidelines and FAQs
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Mastering Third-Party Management in Pharma
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Insights from FDA’s Senior Policy Advisor on Emerging Technologies and AI/ML
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The Fiscal Year 2023 Report on the State of Pharmaceutical Quality
Webinar
Webinar – GMP-konforme Implementierung von KI/ML-Modellen
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