Project manager & Consultant Toxicology, Preclinical Development, Regulatory Affairs

Certified toxicologist with >15 years of experience in the life science area, experimental toxicology, preclinical development for drugs, biologics, medicinal products, project management, CRO, leadership. Profound expertise in regulatory affairs

• Biologie
• Genehmigungsverfahren-Beratung8 J.
• Medizin7 J.
• Medizinforschung

Professional expertise:

toxicological risk evaluations and exposure assessments
toxicological advice and guidance
Permitted Daily Exposure (PDE) assessments according to EMA guidelines
search and review of scientific literature

over 15 years of preclinical (CRO) expertise:
study director, project manager, trainer, head of department
GLP, QA, GMP, toxicology, pharmacology, in vivo, in vitro
international sponsors and collaborations
scientific advice and development of preclinical testing strategies

Regulatory Affairs support and consult:
for international regulatory filings (CTA/IND, MAA/NDA)
Life-cycle management of approval drugs and biologics
Compilation and review of all types of regulatory dossiers and briefing documents

area of expertise:
drugs, veterinary products, biosimilars, herbals, vaccines, medical devices, chemicals, cosmetics

European Registered Toxicologist (ERT)
GLP and GMP study director
project manager