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
What can we do for you?
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Approach & Expertise
Learn how we can support you in meeting your business goals
- Our lean and powerful team with degrees in pharmacy, chemistry, biology, or related studies strive to be of added value to you. Our short reporting lines enable the most efficient road to your success.
- Having one point of contact from our experts backed by the team’s collective knowledge and resources we give reliable advice and execute projects seamlessly.
- At Starodub, consistency and assurance of quality are vital. A quality management system has been implemented and we adhere to GxP and ISO 9001/13485.