At Catalyst, regulatory experts can quickly identify the potential regulatory requirements to meet the local submission challenges. Our experts can predict the issues that can be raised thereby enabling swift approval of the clinical trial projects. From the preparation of regulatory dossiers to the preparation of safety reports as well as clinical study reports, we ensure regulatory compliance at every step of the project lifecycle.

Services

• Dossier Preparation for Regulatory Submission
• Liaison with MOH for Trial Approval
• Coordination for the issue and renewal of Import/ Export Licenses
• Safety Reporting (Table 5, Third Schedule of New Drugs and Clinical Trials Rules, 2019)