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Registration

Registration

In the absence of any pharmacological, immunological, metabolic or biological interaction between the products and the underlying cells, and due to the totally topical, mechanical, filmogen mode of action on the biological surfaces onto which the products are applied, these products are classified as a Medical Devices in the European Union.

For countries outside the European Union, please check your local regulatory laws and requirements, and we recommend the following registration approach :

The polymers are initially selected on the basis of their affinity for VB-Gy. Therefore, polymers act as excipient and need not be presented as active ingredients. In many non-European countries, some products are registered as topical liquid filmogen and osmotically active bandages.

Oct or RX

Depending on the marketing strategy and structure, the products can be sold as Rx or OTC. All hospital products are suggested to be Rx.

Licensing

VITRO-BIO is mainly a pharmaceutical R&D company. VITRO-BIO also has a small production facility. All the products are manufactured at ISO 13485, GMP, or FDA-approved facilities in France.
• Licensing Constraints:
Due to the sensitive, complex nature of polymeric preparations, VITRO-BIO supplies only ready-to-market products.
• Brand:
Possibility to use your own Brand Name.

Dossiers

Complete dossiers are available in English and in French: Technical Files, Pharmacological and Toxicological Studies, Safety, Clinical Efficacy, Stability, Risk Analysis, Conformity with Essential Requirements, Patents and Publications…