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.
Lead and achievement of marketing approval for Arzerra™ in US 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
Ozack experts consist of the founder Ann Christine Korsgaard with 28+ years of experience and Senior Director Christina Balslev Rindshøj with 20+ years of experience, and a large “WEB” of experts connected to Ozack within different disciplines.
Examples of achieved successes are:
- 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
- Numerous experience interactions with various regulatory agencies around the world as FDA, EMA, PMDA, ANVISA, Health Canada, Saudi FDA and others to discuss aspects ranging from initiation of early clinical trials to ensure agreement on the clinical phase 3 development program
Examples of key experience:
- Extensive knowledge on developing and implementing regulatory strategies in all phases of drug development and post-launch.
- Proven track record for meetings with health authorities globally such as FDA, CHMP oral explanation, PMDA and meetings with agencies in Brazil, Egypt, Saudi Arabia, Health Canada and TGA as well as national European regulatory agencies.
- EU procedures for new Marketing Authorization and life-cycle management procedure as variations, extensions, renewals and handling of post-marketing commitments.
- FDA interactions as Pre-IND, EoPh2, Pre-NDA, Type C meetings, new NDAs/BLAs and sNDAs.
- Orphan drug designations and other accelerated procedures.
- NDA submissons in various countries around the world.
Examples of stakeholder management:
- Active engagement in cross organizational project teams to drive new development projects forward together with project management, pre-clinical development, early marketing, medical, clinical operations, biometrics and pharmacovigilance
- Present to upper management on important strategic decisions which include major investments
- Regulatory optimization project management
- Organizational change management