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Regulatory affairs, compliance and quality

Across the world regulations are growing more complex, but solutions are evolving even faster. Learn how our intelligent regulatory, compliance and quality services can help you cut compliance costs while assuring the highest standards of safety and quality.

How we can support you

The scale of regulatory compliance in life sciences today is daunting and it requires a partner with both regulatory compliance expertise and deep industry knowledge.

We are that partner. We support clients with regulatory strategy, regulatory documentation, audits, gap analyses and remediation activities and QMS optimization, managed services and operational QA/RA support at scale.

Our services come from three angles: 

RCQ Consulting

Capgemini brings best-in-class consulting services to optimize your core business processes. We work with you from diagnosis to implementation to bring clarity to simplify and speed up compliance with international Health authorities (FDA, EMA) and national authorities on quality systems, quality products and regulatory (GxP, CFR, ICH, ISO).

Intelligent RCQ

From designing process digitalization strategies to implementing leading digital solutions, we help you gain mastery over your compliance activities. Improve performance, de-risk and accelerate your investments.

RCQ managed services

We transform and manage complex regulatory and quality processes, enabling you to focus on core activities. Call one of our experts to share your challenges and questions, and let us help you accelerate your time to care.

Meet our experts

Frédéric Burger Ph.D.

CTO Life Sciences and Regulatory Affairs, Global Life Sciences Center of Excellence Leader, Capgemini Engineering
Leading the global life sciences portfolio and solutions in Pharma and Medical Devices “This is undoubtedly a new stage in the use of data in the life sciences industry. With the combination of Regulatory Sciences and a clear strategy on Digital implementation, the data is now at the core of any new journey. We support our clients with expertise, strong assets and methodologies for accelerating their transformation”.