Stepping into clinical trials and beyond means entering a very regulated area with options and pitfalls. Ozack can help you get there and ensure value is created through regulatory agency interactions at every step.
In Ozack we strive to live by the OZ principle which means to take accountability for individual and shared success and to stay above the line by being positive and thinking solutions to any challenge. We reach out, seek understanding, give helpful advice and take part in the solution. Every challenge is an opportunity!
Communication - a key to success.
Ozack has SME (Small Medium enterprise) status at EMA in EU which enable us to have close communication with EMA on behalf of all clients. This interaction is an offer to receive advice for free and ad hoc to the regulatory strategy. Ozack at an EMA SME meeting.
Ozack experts consist of the founder Ann Christine Korsgaard with 26+ years of experience and a large “WEB” of experts connected to Ozack within different disciplines. Examples of achieved successes are:
- Lead and achievement of marketing approval for Arzerra™ in US and EU on behalf of Genmab
- Marketing approval in EU and US of Dovonex and Dovobet on behalf of LEO Pharma
- Marketing approval of Dovonex in Japan being the first JND A for LEO Pharma
- Global Regulatory Lead for 30+ early development projects
- Leader for Agency meetings in 10+ countries, EMA and FDA included
- Built regulatory organizations internationally at UCB in Belgium and Shionogi in UK