Preclinical

Preclinical practices are the platform upon which all other drug development rests. В Getting it right the first time is important — you don’t want to be in the position of having to re-do what could have been done properly the first time around. An initial GAP Assessment takes a snapshot of where you are now and compares this with your business goals and product development timeline, thereby providing you with a road map to travel this critical path. Our preclinical industry expertise provides advice that is both realistic and executable.

We can do the hands-on work, such as capturing your primary laboratory data for reports, selecting and managing relationships with your contract research laboratories, planning your critical pharmacology-toxicology programs, and investigating toxicological risks of materials. In addition, we can work with your scientific and technical staff in reviewing and evaluating nonclinical study reports, and in the preparation and/or review of pharmacology-toxicology sections of regulatory submissions.