I help navigate preclinical regulatory requirements

Some of the greatest challenges in investigational device and iterative testing  are created by preclinical test hurdles. Acquisition due diligence,  GLP compliance, animal study design, research controls, data assimilation and interpretation are my specialty. Whether you aim to determine whether you wish to acquire a smaller company's product,  select a winning contract site, verify training and experience of personnel, monitor new or ongoing studies, or prepare regulatory submissions for agency review, I can help.