Together we make a change that matters
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.
30+ early development projects
Global Regulatory lead for 30+ early development projects
50+ years of experience
Within of regulatory affairs and a large web of experts connected to Ozack within different disciplines
10+ countries, EMA and FDA included
We work within Europe, Japan and USA, with a continous expanding to new markets and countries.