Regulatory Affairs
Whether a product is marketed as a medical device, a medicinal product or as a food supplement is not important for most consumers. However, the regulatory burden for market access varies considerably. We advise our clients on what is possible from a regulatory perspective and how the choice will affect the indication or marketability in the long term.
Approval, registration
& certification
As soon as all relevant options have been sounded out and evaluated, our Regulatory Affairs team will get down to work. With a sure hand, we take on all tasks and responsibility for the approval, (traditional) registration or certification of your products.
Over the past decades, our employees have gained extensive experience in the field of herbal medicinal products (phytopharmaceuticals), so that we are very familiar with their special requirements. Due to our expertise in the areas of medical devices and medicinal products, and the close cooperation between our teams, combination products (medical devices with a medicinal component) are also one of our areas of specialisation.