Karyon Biopharma Consulting e.U.
Karyon Biopharma Consulting – getting to the core of non-clinical drug development

Founded

January 2023

Staff

1

Organization type

service provider

Region

Lower Austria

Cluster

LISAvienna

Focus

human health

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