The pharmaceutical and medical device industries are constantly evolving—and so are we!
As a trusted partner in Regulatory Affairs, we have always helped companies meet regulatory requirements while achieving their business goals for market access and compliance. Now, as of April 1st, 2025, we are expanding with a new division: Quality, Compliance & Operational Improvements—offering comprehensive support for both quality and operations.
Meet Our Experts
This new division is led by Michiel van Raalte and Jet Heyse, both Lean Six Sigma Master Black Belts with over 25 years of experience in the pharmaceutical industry. Their expertise spans production, supply chain, and quality, making them invaluable partners in driving operational excellence and compliance.
Quality & Compliance
We provide practical solutions for complex quality challenges. Our expertise includes:
- Resolving quality issues and deviations
- Preparing for audits and inspections
- Setting up and optimizing quality management systems (QMS)
- Implementing EU GMP, Annex 1, and other regulatory frameworks
- Enhancing processes within Quality, including document control, change management, deviation handling, and CAPA processes
Even within established quality systems, processes can be inefficient. We analyze and optimize these systems to ensure they work effectively and efficiently.
Operations, Manufacturing & Continuous Improvement
Beyond quality, we focus on optimizing and supporting operational processes to drive sustainable improvement. Our approach includes:
- Leading Lean improvement initiatives
- Optimizing production and supply chain processes
- Supporting operational teams through change and growth
We combine strategic vision with hands-on execution, ensuring reliability in delivery while achieving lasting results.
With this expansion, we offer a 360° approach to compliance, quality, and operational excellence in healthcare. Let’s build a future where innovation, reliability, and quality go hand in hand!
