Regulatory certainty. Commercial advantage.
Our vision
Together we create Quality & Regulatory Solutions for Healthcare Industry to drive success.
Our Mission
To be a trusted partner that helps start-ups, small and medium sized organizations to build healthy & sustainable Quality & Regulatory Management Systems. We strive to provide the highest standard of expertise and service quality, creating a strong and resilient future for our customers.
What Makes Us Unique
Instead of offering separate services like other consulting firms, we use a holistic approach that covers Quality, Regulatory, Process optimisation, and general management aspects. Our approach is holistic and practical, and has saved millions of euros for many customers. We always take into account the economic aspects of the problem to ensure long-term and financially beneficial solutions for our customers.
Background
Dr. Patel has over 15 years of extensive experience in the Health Care Industry, specifically in the field of In-Vitro Diagnostics. Throughout his career, he has excelled in various areas including Research and Development, Marketing and Sales, Production, as well as Quality Management and Regulatory Affairs. He has worked with organizations ranging from start-ups to global players, and has also held positions as Lead Auditor and Product Assessor (IVDR) at a Notified Body (CE0123).
Dr. Patel has a proven track record of successfully completing numerous projects, such as Cost Reduction, Quality Improvement, Mergers and Acquisitions, and IVDR Implementation. Providing Quality Management Consulting, IVDR Solutions to many companies as well as Quality Management Training in Industry and in Universities. He is holding a Bachelor's degree in Pharmacy, a Master's degree in Biotechnology, and a PhD in International Health.
He maintains collaborations with esteemed institutes and universities.
The foundation of Dr. Patel's services lies in the St. Gallen Integrated (Quality) Management Concept, ISO 9004 (Managing for the sustained success of organizations - A Quality Management Approach), and Six Sigma methods.
With his motto "Less is More," Dr. Patel ensures 100% customer satisfaction.
Get in Touch
We invite you to try our holistic approach and see how we can assist you with your problems. We provide a free 30-minute consultation, where we will evaluate your case, pinpoint the key issues and opportunities, and suggest some potential solutions. This is a good opportunity to sample our services and see if they suit your needs and expectations.