Thought Leadership
Journal Article
The steps to commercialization readiness are complex, multi-faceted and often left too late in the launch strategy of a pharmaceutical product. This can be particularly problematic in Europe where the diversity of national legislation can make supply chain logistics very challenging. Among the issues faced, particularly for non-EU countries, are defining the product’s logistics, identifying stakeholders who will be involved in the supply chain in Europe, and ensuring that all these individuals are ready to assume their roles soon after the product’s approval (Marketing Authorization) with the relevant Licences and Quality Technical agreements in place.
Journal Article
One of the biggest challenges when launching a product in the EU is understanding the complex regulatory landscape. Besides the overarching European legislation, each country has its own national requirements for the supply of medicinal products.
Infographic
We have the know-how to support your companion diagnostic (CDx) project through its entire lifecycle, from idea generation all the way through registration and postmarket. Regulatory requirements for CDx vary significantly by region. They must be aligned with a specific medicinal product (International Non-proprietary Name, INN) registration. This process necessitates dual expertise, we can manage the intricacies of CDx and their unique regulatory pathways in all major markets.
Blog & Article
- 20th September 2024
Blog & Article
- 17th September 2024