Profile: Wolfe Laboratories, Inc. (WLI) provides a knowledge-based approach to preclinical development needs of our biopharma clients. We provide solutions to solve challenging problems in the areas of in vitro ADME and PK, formulation, and analytical characterization. The types of formulation development studies conducted by us vary and reflect the range of administration routes employed in clinical practice. We mainly focus on oral and intravenous routes of administration. In addition to developing stability indicating analytical methods, we identify impurities and degradation products from solid API material, as well as formulated product using HPLC/MS/MS.