We are a team of interdisciplinary non-clinical development experts with many years of experience in pharma, biotech and contract research. With our broad skills and experience we cover the three main areas of non-clinical research - Pharmacology, ADME, Toxicology. Our team is supported by Senior Experts who can assist us and you as our client in all kinds of sophisticated preclinical questions.
Gerhard Hager, PhD | CEO
Gerhard Hager has over twenty years experience in the preclinical development of Biologics (NBEs), Biosimilars, Small Molecules (NCEs), Antibodies and ATMPs, such as cell and gene therapeutics.
In his many years as a founder, scientific director and managing director of a midsize international full service research institute (CRO), but also as a senior executive in the pharmaceutical industry, he has overseen the various stages of development for many products, from drug discovery right through to market approval. Having worked as a GLP-Test Facility Manager in several countries and companies of different sizes, he is a proven expert in Good Laboratory Practice (GLP).
Veronika Ehrlich, PhD | MAS (Toxicology), ERT (European Registered Toxicologist)
Veronika Ehrlich has more than 15 years of international experience in various fields of toxicology. She started her career in genetic toxicology and worked in the following as project manager and toxicological risk assessor in the food industry (chemical food safety), including the application of in vitro bioactivity assays in risk assessment.
After moving to the pharma industry as a regulatory toxicologist in non-clinical drug development, Veronika was responsible for the preclinical section of submission documents (IND, IMPD, BLA, IB, CTS, NDA) and annual updates, and supported the registration of numerous drugs. She was part of international scientific task forces (ILSI – Institute of Life Sciences Europe; EFPIA - European Federation of Pharmaceutical Industries and Associations) and cooperated with the Environmental Agency Austria. Her experience includes managing agency inquiries during the life cycle management of products and conducting risk assessments/safety evaluations of active drug ingredients, excipients, and impurities (extractables and leachables).