Who We Are

Peter Korytko has over 15 years of pharmaceutical/biotech industry experience (Pfizer, Amgen, and Preclinical GPS) with preclinical development of small molecules, monoclonal antibodies, proteins, and oligonucleotides preceded by a PhD (Cornell University) and MBA (DePaul University). In those 15 years, Peter supported 36 clinical trials and regulatory filings including 21 INDs, numerous Phase 2 starts, bioequivalence trials and supplemental NDA. Peter’s experience includes designing ICH compliant programs; implementing over 196 GLP toxicology studies and over 800 total preclinical studies; conducting numerous PK/PD/ADME and pharmacology assessments; outsourcing and monitoring external studies; supporting clinical development and regulatory affairs; leading teams; strategic publications; communicating recommendations to management; and interacting with regulatory agencies (FDA, Health Canada, and EMA).

The Company

Preclinical GPS LLC was originally formed as Preclinical Safety Consulting. The name of the company was changed to Preclinical GPS – Global Preclinical Services LLC with the expansion of services beyond preclinical safety and the opening of company offices and affiliates in the US, Canada, and India.

Peter Korytko, PhD, MBA

Peter Korytko, PhD, MBA