Regulatory Submissions and Support
With more than 30 years of global regulatory experience, Confidence Pharmaceutical Research expertly navigates the complexities of submission processes. We collaborate with local regulatory specialists to guide sponsors through each step—accurately, efficiently, and with full compliance. Regulatory requirements vary significantly by country, and without expert guidance, even small missteps can lead to costly delays. From navigating Ministry of Health expectations to IRB coordination, we reduce complexity and speed up approval.
How We Do It?
- Country-Specific Regulatory Planning
- Define submission pathways aligned with local agency processes and approval sequencing
- Evaluate regulatory feasibility during study startup to plan for roadblocks early
- Process and Document Management
- Provide region-specific process flows, checklists, and timeline expectations
- Manage documentation including PI certifications, import/export permits, and site contracts
- Stakeholder Communication
- Act as liaison with Ethics Committees, IRBs, Competent Authorities, and Ministries of Health
- Schedule and support pre-submission meetings with FDA, EMA, and others
- End-to-End Submission Management
- Handle initial applications through final approvals
- Adapt processes for local-before-national, dual ECs, or country-specific nuances
What Sets Us Apart?
- Regulatory specialists in each region ensure local compliance with global consistency
- Expertise across major regions including FDA, EMA, UK MHRA, and non-EU Europe
- Full-service support from startup documentation through post-approval compliance
- Flexible to each sponsor’s structure: centralized or decentralized regulatory models