The moment of launch usually refers to the time when a pharmaceutical company has received Marketing Authorization and may start supplying the product to the healthcare system, to wholesale and retail channels.
Launch is the beginning of a critical period in product commercialization, when the intense effort and resource poured into the medicine finally begins to pay off.
Preparation for launch must begin well in advance – in many cases before starting the pivotal (phase 3) clinical trial. That is why, at least for global projects, the timeline may stretch over years. This kind of work will involve a great deal of planning, ideally done in cooperation by the Regulatory Affairs and Market Access functions. Their joint effort will help map out exactly what needs to be done to launch on the target market.
Why trust Arex Advisor with the launch of a pharma product?
Every country, even within a compact region such as the Nordics, is unique. That is why preparatory work for Marketing Authorization must go hand in hand with a mapping of the reimbursement landscape.
Arex Advisor can support you with:
- Creating a launch plan, taking into account all regulatory and market access activities
- Engaging key opinion leaders to validate current clinical practice in the disease area
- Developing compliant artwork for the local market, including blue box requirements and regional item numbers
- Updating and maintaining national databases for supply and information on the medicines
- Preparing country specific HTA strategies
- Fine-tuning your value message to present the product in the best way
- Localizing economic models to country specific context
- Submitting a reimbursement dossier with the highest chances of success
- Preparing, submitting and distributing educational materials (additional risk minimization measures) to comply with the product’s conditions for marketing
What is the result for you and your project?
There will be just one opportunity to launch a given product in a new market for a specific indication. From a Market Access perspective, however, you have a chance to re-submit a dossier for reimbursement in case in was not approved the first time.
Arex Advisor’s consultants have experience both with launch strategies, resubmissions and day-to-day operative support so that your product is given the best possible start on the market.