Together we make a change that matters

About Ozack

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

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
601x871_11.9.20200134

Camilla Vissinger

Regulatory Affairs Associate


Contact: cvi@ozack.dk

601x871_11.9.20200005

Ann Christine Korsgaard

Regulatory Affairs Executive


Contact: ack@ozack.dk

601x871_11.9.20200949

Christina Balslev Rindshøj

Senior Director


Contact:  cri@ozack.dk

601x871_11.9.20200055 1

Ivana Glatzová

Regulatory Affairs Manager


Contact: igl@ozack.dk

ring

“Inspiring, visionary, energetic, hardworking, generous and a fantastic communicator who truly loves and lifts people. Result-oriented networker, who transforms love to gold through her high level of emotional intelligence. That is Ann Christine.”

Per Leth-Nissen

President & CEO, CXOPeople

“Ann Christine is a highly talented and experienced regulatory expert with a refreshing and energizing working style. She is a joy to work with and consistently delivers results of very high quality, within the agreed time frames.” 

Jan van de Winkel

President and CEO, Genmab AS

“Ann Christine always provides qualified and on time help to the complicated regulatory process especially when it relates to biologics."

Claus Møller

CEO, Y-mAbs Therapeutics, Inc.

“Flexibility and commitment combined with experience and professionalism was how Ann Christine ensured that our project was regulatory compliant and completed on time.”

Anders Ljungqvist

CEO, RhoVac AB

Contact us

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Ozack ApS
Ole Maaløes Vej 3
2200 Copenhagen N
Mail: info@ozack.dk
Phone: +45 25 40 30 00

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