Your questions. Our answers.

General Informations

The legal manufacturer is still Vitrobio. Its name and address appear on the packaging. The marketing company is indicated as the "distributor".

Yes, for some products we have 2 to 3 possible formulations. These are not shown on the website. The point is to be able to benefit from exclusivity on a formulation in a given territory.

EXCLUSIVITY: means that only one distributor has the right to market the specific FORMULA of a PRODUCT in the country(ies) of the TERRITORY agreed upon.

SEMI-EXCLUSIVITY: means that the DISTRIBUTOR has the right to market the specific PRODUCT FORMULA in the defined TERRITORY, but that VITROBIO may subsequently appoint a second partner of its choice who may sell the same PRODUCT FORMULA using another brand or trade name.

Total annual order volumes are contractually defined, generally over 3 years. Depending on these quantities, the distributor may or may not be eligible for exclusivity on the formula. 

Next, production orders are set at 20,000 units (minimum quantity to enable the production line to manufacture).

Yes, our products are turnkey, with all the necessary documentation. 

In Europe, registration is straightforward, requiring only a simple declaration. Files are kept by Vitrobio and made available to the authorities. Our regulatory team works hand in hand with your teams to help you meet all regulatory requirements. 

Outside Europe, it is necessary to register the medical device. This procedure is handled by the distributor, assisted by our regulatory team.  

Our notified body under the directive (MDD) and under the regulation (MDR) is GMED. ( https://lne-gmed.com/fr )

We are accredited to ISO 13485 for medical devices.

All our products are already in the certification process. They therefore benefit from the transition period until 2027.  Vitrobio should obtain MDR certification during 2024. 

We have 2 production lines, one of which is subcontracted. 

A 3rd line is also being created on our premises (2025). 

Each line has a capacity of around 25,000 products per day.

We can't develop a new formula especially for a distributor. Developing a formula takes several years, with clinical, pharmacological and toxicological studies, etc., to set up. 

Furthermore, the 2017-745 MDR regulation does not allow us to extend our product range immediately.

What shipping incoterm do you use?

We work on an EXWORK (ex works) basis. The distributor takes care of transport. (25°C)
Customs code : 300490

Concerning products

Filmogen Glycerol to attract hypotonic liquid & plant-derived polymers to block undesirable proteins.

Glycerol is a food ingredient, used as a preservative in canned food, to store and to transport cells and organs and in many cosmetics and oral syrups. It is like a concentrated sugar or honey solution (without contaminants), obtained from plants (vegetable origin), and due to its osmotic properties (like a sugar solution), it attracts hypotonic liquid from the internal parts of the tissue onto which it is applied. This liquid flow equally dilutes glycerol and therefore glycerol can remain on the live biological surfaces only for a few minutes. Therefore, we added a very small quantity of some fruit & / or plant extracts having high tannin content. Tannins (such as the deposits seen in the red wine bottle) are totally inert, very big and branched molecules having properties to bind with many macromolecules and proteins (ex. tanning the animal skin into leather). We incorporated these plant extracts in the glycerol solution to render glycerol filmogen for a long lasting (6-8h) activity. 

These  plant  tannins  may  also  capture  other  impurities  present  on  the biological surface so as to clean the surface.

To  improve  the  filmogenicity  of  the  product.  Being  rich  in  tannins (polymers), they also bind with protein molecules.

Mechanical effect because the product has no interaction with any underlying cellular structures, and has no chemical, pharmacological, receptor-binding, metabolic or immunologic effect on the underlying cells. This is why there is no toxicity.

Our patent covers technological innovation based on glycerol and polymers. It therefore covers all our products. The license is held exclusively by Vitrobio, although our distributors benefit from the patent protection indirectly by marketing our products.

Are your products sterile?

No.  Being  self  – antiseptic,  they  don’t  need  production  under  sterile environment  (but  under  air  filtered,  clean  environment ISO 8).