Services: Overview

Cato Research has in-house capabilities to assist sponsors with all aspects of the drug development process, including the following activities:

Design and execution of regulatory strategy
Design, development, implementation of preclinical/toxicology development programs and plans as well as management and monitoring of preclinical/toxicology studies
Design, conduct, and management of Phase 1 through Phase 4 clinical studies
Management of data processing/data management activities
Generation of statistical analyses
Production of integrated statistical/clinical study reports
Preparation, compilation, and submission of regulatory applications, including: INDs, NDAs, CANDAs, ANDAs, BLAs, CAPLAs, PMAs, ELAs, IDEs, 510Ks, Orphan Drug Applications, and Grants, Annual Reports
Management of Chemistry, Manufacturing, and Control programs
Management and conduct of cGCP, cGLP and cGMP audit and compliance activities
Management and conduct of due diligence activities for emerging technologies

Our expertise in devising regulatory and product development strategies is directed by senior staff members who have many years of experience interacting with the FDA, the HPB, and other international regulatory agencies.

Cato Research's detailed knowledge of the intricacies of regulatory agencies and the reputation Cato Research has established helps to promote and coordinate constructive formal and informal regulatory agency meetings for sponsors.

Our goal is your goal.

All of our regulatory strategies are based on your corporate objective, whether this objective is to out-license your innovative technology; to conduct a pre-approval meeting with the appropriate regulatory agency; or to obtain full regulatory approval for your drug, biologic, or medical device.