Regulatory

Regulatory

 

While handling the set of application sheets or key regulatory elements, we ensure that your data are presented more effectively, aligned  with the requirements of local regulatory organisms. This allows to ensure best possible chances to approve the application.

 

The management of complete accreditation request does not consist only in  knowing the different directives requirements. Our experts have succeeded indeed the follow-up of several Marketing Authorization Applications (MAA) during last years. This work includes  record preparation according to regulatory requirements and realities of request handling in all its aspects, ALLIANCE INFOMED offers thus to you its expertise and experience.

 
Regulatory Services

Understanding the complexities that surrounds the Tunisian regulatory requirements and the way they are applied plays an essential role along the development and maintenance of new medicine.

Having this authorization for the first time while being endorsed by an experienced team at your disposal to bring strategic advices and support that keeps you in the good way, considerably increases the chances that your product gains the market and reaches its objectives.

The practice and experience of ALLIANCE INFOMED team covers all the therapeutic domains of all medicine development steps. We understand how to integrate the regulatory requirements in Tunisia into your development plan, in order to help you obtain the regulatory approval and commercial success of your products.

We can bring you effective support to obtain the approbation of your product in Tunisia. If you have already a presence in Tunisia, we may become your team extension to widen your field of actions and increase your product's marketing shares.

Our goal is to help you win time, reduce costs, optimize resources and increase your success chances.