Submission

Client need

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.

Our solution

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.

Client need

The client is a European pharmaceutical company who plan to expand their territory to the Nordics. They need to have a local organization in place to plan and execute the launch of products to the market. The product portfolio consists of several products where some have already gained market authorization in the Nordics, while some are still in the registration process.

Our solution

This case is a project that will involve several functions.

Arex Advisor will set up and lead the project. The first steps will include establishment of the client company on the local market/s, and set-up of company functions and the distribution chain.

We will manage the finalization of the registration process together with the client and make all the necessary regulatory steps to prepare for the product launches. After launch we will run the life-cycle management for the products on the market.

Arex will lead the price and reimbursement submissions to the Nordic HTA agencies. We will write the reimbursement dossiers, develop a cost-utility model to demonstrate cost-effectiveness and interact with the local HTA agencies during the entire assessment process.

Client need

Gain reimbursement for their product in Sweden. The product is an orphan drug targeting a rare disease with limited treatment options.

Our solution

To achieve optimal market access for your product, reimbursement is a key step. Our team offers support with the development of a reimbursement strategy for the submission to the health technology assessment (HTA) agency. With a submission strategy in place, our team will write the reimbursement dossier and develop a health economic model to demonstrate cost-effectiveness. To populate the model, we will perform literature reviews and interact with key opinion leaders to identify and validate appropriate assumptions and input parameters.

We can assist during the assessment process with both strategic and technical support, including participation in meetings with the HTA assessors and performing additional adaptations of the health economic model.

To support reimbursement for the product in the remaining Nordic markets, we will adapt the dossier and the cost-utility model to fulfil local requirements of other HTA bodies.