The submission process is about much more than compiling your data and submitting it for review. It’s an opportunity to present your dossier and product in the optimal way to give your product the best chance to succeed on the market. We have the experience needed to achieve high quality submissions and have successful interactions with both regulators and HTA bodies.
The client is a newly started company that has acquired a portfolio of products registered in more than 30 countries. They need to quickly have a regulatory affairs organization in place to plan and execute the transfer of the product licenses. Furthermore, set up of processes for the lifecycle management of the products is needed.
Arex Advisor can quickly set up a project team to handle the MAH-transfer of the products in the various global markets. Timelines will be set up together with the client, considering differences in local regulations and business needs.
We will be managing the project, compiling the dossiers and ensure a timely submission of the applications to the local authorities. We will collaborate closely with the client to ensure a smooth transfer, and avoid stock out situations and unnecessary scrapping of goods.
In parallel to the transfer of the licenses to the client, Arex will be responsible for the lifecycle management of the products. Senior Global Regulatory Project managers will take on the responsibility for designated products, working closely together with our experts in CMC and Clinical Regulatory Affairs to set up product strategies and prepare regulatory submissions. We will also handle the product information and artwork for all markets, including translations to local language.
Arex Advisor will be responsible for all regulatory submissions and contacts with local authorities. Defined processes and highly qualified professionals enable an effective and compliant lifecycle management, where the client can focus on their business.