Kresimir Pucaj

has over 33 years of extensive experience in veterinary medicine, experimental pathology and nonclinical toxicology, out of which about 26 years have been spent in a contract research organization, conducting and directing nonclinical toxicity studies. He has in-depth knowledge of various ICH/FDA guidelines related to preclinical pre-IND (pre-CTA) drug development. He has extensive experience in the preparation of protocols, directing studies and writing preclinical study reports to meet standards of ICH/FDA/TPD/OECD and EU guidelines.

He has also been involved in directing clients on product development strategies to meet international regulatory request and preparation and management of nonclinical drug development programs (IND Enabling to Phase III). Dr. Pucaj received his DVM and Diploma in Small Animal Medicine from the University of Zagreb (Croatia), he is a Member Emeritus of the College of Veterinarians of Ontario, received a MSc in pathology from the University of Toronto, and is a Diplomate of the American Board of Toxicology.

He is included in the external Scientific Experts Database for the Therapeutic Products Directorate of Health Canada, for the expert advice or review and recommendation on nonclinical and toxicology data.