Karl Landsteiner University of Health Sciences (KL Krems) at Campus Krems offers a modern, demand-oriented education and continuing education in medicine and psychology as well as a PhD programme in Mental Health and Neuroscience. Research at KL Krems is marked by scientific collaboration between different departments from key fields of health sciences, medicine and psychology. The three university hospitals in Krems, St. Pölten and Tulln and the MedAustron Ion Therapy and Research Centre in Wiener Neustadt guarantee clinical teaching and research of the highest quality.
Karyon Biopharma Consulting e.U. supports clients during non-clinical drug development.
Services encompass:
• Design of product-tailored non-clinical development plans for medicinal products to enable CTA/IND (small molecules, biologics, ATMPs (cell- and vector-based), vaccines)
• Support in CRO selection and placement of studies at CROs (request for proposals for complex non-clinical programs, CRO comparisons up to placement and elaboration of detailed study plans)
• Involvement in study designs for non-GLP and GLP studies, monitoring and study report reviews, including data interpretation
• Support for regulatory questions: early regulatory strategy, preparation and conduct of regulatory interactions with regulatory Authorities, including coordination and moderation of Scientific Advice Meetings (national Authorities / EMA / FDA)
• Scientific writing of a broad range of (regulatory) documents, including non-clinical parts of Briefing Documents for Scientific Advice Meetings, IBs, non-clinical summaries and overviews of CTDs / INDs, non-clinical ATMP certification dossiers
• Preparation of different types of toxicological risk assessments / expert statements
• Preparation of biological evaluation reports (BERs) for substance-based medical devices
For further details, please contact me at a.guenzl@karyon-consulting.com
Das Know Center ist ein führendes europäisches Innovations- und Spitzenforschungszentrum für vertrauenswürdige KI und Data Science. Mit State-of-the-Art & Beyond Technologien, Spitzenforschung im eigenen Haus und hochinnovativen Projekten mit Kunden aus Industrie, Energie und Health Care stellt der Grazer Innovationshub die Transformation der neuesten Erkenntnisse auf dem Gebiet der Data Science und KI in konkrete Wettbewerbsvorteile für Unternehmen sicher.