Product Registration

A successful product registration is the way to a successful marketing authorization.

MERAS manages the whole registration process:

Compiling dossiers
Completion of country specific forms
Preparation of price certificates
Continuous assessment of the dossier and providing the right solution

MERAS provides regulatory affairs advice at all stages: before submission of a dossier for marketing authorization, during the registration process and after submission by extensive follow-up.

Our experienced team will evaluate the most appropriate strategy to register your product in the Middle East and Africa region. Full support can be provided to prepare the registration file, support with the validation phase and the Response to Questions.

MERAS can be your preferred partner to support the registration of your medicinal product in the Middle East and Africa.

Our experienced team have knowledge and expertise that spans all product types; from traditional pharmaceuticals and generics, to vaccines, biologics/biosimilars and other advanced therapies.