To provide preclinical/toxicology consulting support to the pharmaceutical industry to facilitate the development of safe drugs for human use.
We do that through providing guidance for the preclinical safety assessment including the preparation and review of regulatory submission documents, monitoring preclinical studies at contract laboratories, interpreting toxicity study results, conducting gap analysis, preparing summary documents for the preclinical safety assessment package, reviewing the safety of inactive ingredients and excipients, and strategic preclinical development planning.
Dr. Morseth is the principal consultant with 25 years of experience in toxicology assessment of drugs and preclinical drug development. She received her Ph.D. in 1984 from Washington State University in Experimental Psychology. She joined Hazleton Labs (now Covance) that year and served as a study director for developmental and reproductive studies until joining the FDA in 1990. While at the FDA she worked at both CDER and CBER as a pharmacology/toxicology reviewer. She was a member of several intercenter committees including serving a chair of the FDA (CDER/CBER) Developmental and Reproductive Toxicity committee where she both advised other reviewers and participated in the ICH guideline development process. After leaving FDA she again joined Covance as the Associate Director of Toxicology with responsibility for the scientific direction of small animal and developmental and reproductive toxicology. She left there in 1998 to join Quintiles where she served as a preclinical consultant providing scientific and regulatory advice to companies developing pharmaceutical products in the US, Europe, and Asia. Since then she continued to serve as a consultant first for Milestone Biomedical Associates (a division of Charles River Laboratories) and now is an independent consultant specializing in the science and strategy of preclinical drug development.
In addition to Dr. Morseth, Morseth Consulting, LLC works closely with other consultants in various disciplines needed to provide guidance to develop drugs from the preclinical stage to submission of the marketing application.