GxP-CC Services

GxP-CC delivers comprehensive compliance services that help life sciences companies weave sound data and quality practices throughout the entire value chain. Our diverse team of scientists, pharmacists, engineers, and data experts blend big-picture perspective with hands-on solution building. The result is a streamlined approach to quality-driven compliance across clients’ global sites and throughout every product phase.

We customize data-driven solutions that put quality first 

Compliance is non-negotiable, but the path to achieving it can take many directions. That’s why we emphasize a collaborative, lean approach to compliance services that allows for flexibility. Organizations can select from the services they need to create a consistent compliance strategy. Our breadth of knowledge, across product phases and software solutions, allows us to cover more of the value chain for a truly global approach to quality.  

With services across the life cycle of validated computer systems and end-user product development, we help organizations achieve new levels of quality and efficiency in product development.

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The Benefits and Challenges of Digitalization in the Lab -Lab 4.0-
Blog
AI/ML in Drug Manufacturing: FDA’s discussion paper and PDA’s comments
Webinar
Shielding Critical Life Sciences Data from Cyber Threats
Blog
Navigating AI Implementation in GxP Environment
Blog
Unleashing the Power of Technology in Clinical Trials: FDA’s Latest Guidance on Electronic Systems, Records and Signatures
Blog
Artificial Intelligence in GxP Regulated Environments: How to Harness its Power While Mitigating Risks
Blog
Summary of APIC’s FAQ document on Data Integrity
Blog
Highlights des Konzeptpapiers zur Annex 11 Revision
Blog
How ISO 27001 certification ensures data integrity
Blog
Common Data Integrity Points of Failure: 3rd Party Management
Webinar
Data Integrity in Pharmaceutical Manufacturing, March 23, 2023 – Recording available
Blog
Highlights of the Concept Paper on the revision of Annex 11
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