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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

CTO Life Sciences & Regulatory Affairs Life Sciences Lead, Center of Excellence
Frédéric leads the compliance community at Capgemini Life Sciences. He brings 22 years of experience in BioPharma on NCE/NBE and MedTech. His focus on implementation of regulatory sciences throughout the value chain has helped numerous businesses streamline their processes and accelerate time to market. At Capgemini, Frédéric leads the Global Center of Excellence for Life Sciences and manages the Intelligent Regulatory, Compliance and Quality offering.

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
Brian is an executive and consulting leader in the Life Sciences industry. He has three decades of operations transformation, management consulting and leadership experience. He has developed and led global Lean and Digital programs, consistently recruiting and developing a diverse array of talent and has led global business integrations, executed a range of process and product programs and directly supervised operations of technical processes.