Regulatory categories

FIDELIO Healthcare produces medicinal products, controlled drugs, medical devices and food supplements. The primary focus is on medicinal products. The manufacture and sale of these products are subject to the strictest quality and hygiene guidelines, which we fully comply with at our production facility in Limburg an der Lahn.

We are also certified for the most important export countries worldwide, although the regulations for medical devices and medicinal products vary considerably in some cases from country to country. The different classifications pose a particular challenge: depending on the target market, an item may be designated as a medicinal product in one country, for example, but as a medical device in another. We are familiar with these pitfalls and know how medicinal products and medical devices can be marketed successfully worldwide. We therefore see ourselves not only as contract manufacturers, but also as consultants for products requiring extensive explanation. Our customers benefit from the expertise we have accumulated over decades.