Our services - Marketing Authorization

Marketing authorization

The Marketing Authorization guarantees that the medicine was evaluated with rigor in terms of quality, safety and efficiency before being available for the customers. This evaluation aims at protect patients and insure that the medicine's benefits prevail on the potential risks.

I want to conduct a study

L'image représente des médicament pour illustrer l'autorisation de mise sur le marché

Deliverables
Our team brings you an assistance for your maneuverability and lisibility studies :
‍3 main criteria are evaluated :

Quality (control procedures that are applied to ensure the consistency and reliability of the manufacture process)

Safety (evaluation of the predictable adverse effects related to use as well as their frequency or the precautions for use).

Efficacity (identification of the exact use conditions of the medicine and establishment of a positive risk-benefit balance for the commercial authorization)

Lisibility test

Our team brings you an assistance for your lisibility studies to make sure that the medicine's IFU is clear, affordable and understandable for the general public.

IFU | User testing | Analysis | Protocol | Report

L'image représenta un test de lisibilité concernant une notice d'utilisation d'un médicament.

Maneuverability test

We also support you for your maneuverability studies to evaluate the ease of use and the medicine's ergonomics as well as its administration device.

Protocol | Analysis | User Testing | Report

L'image représente un test de maniabilité.

Need for assistance ?