Management of Nonclinical Studies

Depending on the compound (e.g., NCE, new biologicals, gene therapies, reformulated existing drugs, (505(b)(2), follow-on biologic), the length of the nonclinical program can vary from months to several years. This process requires continuous tracking of the program to ensure careful management of research material supply, timely execution of studies, prompt generation of reports, and appropriate updating of supporting documents (e.g., IB, IND). PharmaLex consultants are experienced in the management of even the most detailed Nonclinical programs and can provide clients with the resources needed to ensure the studies are done on time and as planned.