Cato Research has in-house capabilities to assist sponsors with all aspects of the drug development process, including the following activities:
- Regulatory assessments and strategy development
- Regulatory interactions
- Preclinical/toxicology development programs, study management and monitoring
- Phase 1 through Phase 4 clinical study design, implementation, trial management, and monitoring services
- Data management
- Statistical analyses and integrated statistical/clinical study reports
- Regulatory submissions and e-submissions
- Chemistry, Manufacturing, and Control programs
- Audit and compliance activities for cGCP, cGLP and cGMP
- 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 has detailed knowledge of the intricacies of regulatory agencies and an established reputation that helps to promote and coordinate constructive formal and informal regulatory agency meetings for sponsors.
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.