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Company Description
Ozack ApS is a Denmark-based regulatory consultancy specializing in guiding biopharma and medtech companies through complex global drug development pathways. Operating from Frederiksberg, the firm helps teams Navigate, Connect, and Communicate—the three pillars that define its offering. Under Navigate, Ozack builds global regulatory strategies, performs gap analyses, and delivers regulatory intelligence by interpreting precedent, guidance, and evolving regulations, ensuring that risks are understood and mitigated before key decision points. Within Connect, the team prepares high-quality regulatory dossiers that coherently tell the scientific story across disciplines for interactions and submissions including pre-CTA/pre-IND meetings, Scientific Advice, End of Phase II, orphan and expedited designations (e.g., Fast Track, PRIME, ATMP, Breakthrough), pediatric plans (PIP, PSP, PPSR), clinical trial applications (CTA, IND), and marketing authorizations (MAA, NDA, BLA). Complementing this, Communicate focuses on agency advice, stakeholder communications to boards and partners, investor-facing planning around regulatory value inflection points, and due diligence support that emphasizes documentation integrity and Good Documentation Practice. With a combined 70+ years of experience across 50+ development projects and 30+ countries—including the EU and EEA, the UK, USA, Canada, Japan, Australia, South America, China, Turkey, and wider Asia—Ozack’s consultants bring deep therapeutic exposure spanning oncology, dermatology, diabetes, haemophilia, obesity, pain, neurology, growth disorders, stroke, inflammatory and rare diseases, diagnostics and more, as well as modalities from small molecules and biologics to vaccines, antibodies, ATMPs, and drug-device combinations. Founder and Global Regulatory Affairs Expert Ann Christine Korsgaard leads a seasoned team that assembles plug-in networks of subject matter experts when needed to address specific program questions. The company maintains active professional engagement through memberships in TOPRA, Dansk Biotek, DIA, the Danish LifeCycle Community, and the Board Assure alumni network, reinforcing its commitment to continual learning and high standards. Ozack’s mission is simple: together with clients, make change that matters by turning sound science into approvable, patient-focused regulatory outcomes.
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