While the Marketing Authorization is underway the commercialization strategy must be set up and executed. By gaining understanding of the clients’ commercial needs, we add the EU regulatory complexities in a simplified way. The Qualified Person mentioned in the importer license is also key for the release of the medicines to the EU market. This Manufacturer Importer Authorisation (MIA) or MIA License is granted by the national regulatory authority after inspection of the site. We can support the application up to the successful granting of your pharmaceutical licenses while providing the required and adequately trained QP from our company.
Supply chain model
Next step is designing a plan for the supply, the distribution and transportation to the various EU markets. This supply chain model falls under the scrutiny of the GDP regulations and requires companies to have a pharmaceutical GDP License. We will optimize the supply and build a scalable and resilient supply chain model for your products in the years to come. All will be aligned with pharmaceutical regulations and license requirements.
Market Access Program