Product Qualification

Product qualification is a critical service for manufacturers navigating the complex regulatory landscape.

Determining the correct regulatory status of a product is essential, especially for borderline products that could be classified as medicinal products, medical devices, combination products, cosmetics, consumer products, or other categories.

The classification depends on several factors, including the type of product, its mode of action, intended purpose, and the claims made by the manufacturer. Some of these qualification decisions can be complicated especially if there is less guidance and clarification on these products.

Accurate product qualification helps manufacturers understand all possibilities and pitfalls related to their products, ensuring a smooth and compliant market entry. Our team provides comprehensive services to define your product’s correct regulatory status, offering guidance and insights to navigate the regulatory landscape effectively. 

We handle product qualification in multiple ways

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Patrick Vronen
Management team member - Senior RA Manager

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Patrick Vronen
Management team member - Senior RA Manager

Let's Connect

Talk to an expert