What a Solid Regulatory Affairs Team is Made From
Medis' Regulatory Affairs team is solid, constantly ready to tackle any new regulation or spontaneous challenge brought up due to the ever-expanding product portfolio and growing customer base. Here are 6 reasons why the team is always ready for action:
1. We're a solution-oriented team. We're constantly exploring and finding regulatory pathways to shorten approval timelines, for the benefit of our customers.
2. We're flexible and efficient. We know what it takes to provide excellent service to our customers in Europe and non-EU markets. Our team in Iceland supports new registrations in Europe and international markets, and our Lifecycle Management team in India takes care of the customer and product in the long haul, including any product variations over the years.
3. We have expertise that counts. We know and understand how to deal with different Health Authorities and varied regulatory pathways, which means we're able to understand customers' diverse needs and orient them the correct way. Our team of professionals have wide and varied backgrounds — mainly sciences, but also legal, management and languages including Spanish, Bulgarian, German, French, Hindi, and Nordic languages.
4. We have the ability to manage a broad portfolio. We support more than 400 marketing authorization holders, over 200 products, and more than 5500 marketing authorizations. We’re proud of these numbers!
5. We provide ready-made EU variation packages to customers. Every time a change is made to the manufacturing process, we receive a variation package from the manufacturing site that we then tailor for each client. We partially fill out the application form and give them all supporting materials, and then the customer takes care of the actual submission to the authorities. For international markets, it works slightly differently. We provide them with the package, and they fill out their own application in their language and format.
6. We closely support customers worldwide from their first interest until end of supply. No matter which market the agreement covers, or which product, we support them throughout their journey with Medis.