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Intelligent Regulatory, Compliance and Quality

Regulatory science made simple

Our best-in-class consulting and managed services combine deep sector know-how with extensive regulatory & compliance expertise. Intelligent RCQ leverages data & digital technologies to achieve quality and regularity compliance, resulting in rapid deployment, improved performance and consistent excellence in quality.

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

RCQ consulting

Our consulting services optimize core business processes and support organizational transformations in R&D, manufacturing, quality, regulatory and distribution. From diagnosis to implementation, we bring over a decade of experience working on quality systems, quality products and regulatory with international health authorities (FDA, EMA) and national authorities (GxP, CFR, ICH, ISO…).

Intelligent RCQ

From design of process digitalization strategies to implementation of cutting-edge digital solutions, we enhance the monitoring, processing and mastery of your compliance activities to improve performance, de-risk and accelerate your investments.

RCQ managed services

For researchers who want to focus on their core strengths, we fully manage context regulatory and quality processes. We work with you to transform your regulatory processes into a tailored & agile approach that optimizes compliance TCO* and performance.

As an example, we ensure streamlined technology transfers with robust methodology and multidisciplinary expertise including Project Management, Quality Management, Regulatory Affairs and Supply Chain. We provide a robust transfer methodology with a detailed Transfer Project Master Plan to ensure alignment across all different stakeholders on timelines, steps and responsibilities.

Regulatory, Compliance and Quality require a significant share of R&D resources, effort and attention. Our Intelligent RCQ capabilities were built to simplify the complexity and help you teams focus on the tasks that matter most to you.

Find out how Intelligent RCQ can further your R&D.

Intelligent RCQ as a value accelerator

Becoming data-driven is critical for future-proofing life sciences research – but many companies are struggling to achieve it

Meet our experts

Cláudia Vilhena

Senior CQR Engineer, Capgemini Portugal
“Quality is the watermark of trust in products and services” Cláudia has 15+ years’ experience in the pharmaceutical industry. She is currently responsible for the analytical flow of several projects under development, validation and transfer. Cláudia brings strong experience in project management and Quality Assurance systems, processes and teams, with a focus on product release.

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”.

Camille Planty

Senior Solution Manager, Life Sciences – R&DHead of Belgium Agile Compliance Center of Excellence at Capgemini Engineering
After 10 years in the pharmaceutical industry and 5 years now as Solutions Manager, Camille Planty has experience supporting R&D, QC, Clinical & RA processes.

Brian Eden

Vice President, Global Life Sciences Technical Operations Leader, Capgemini
Leading process and digital solutions in Pharma and Medical Device Operations “We are at an exciting moment when our data systems and analytics are finally capable of helping us fulfill the promise of Industry 4.0 for Pharma and Med Tech. We must move digital transformation forward boldly, all the while keeping our efforts grounded in the fundamentals of data architecture and Lean Thinking that got us to where we are today. “