Regulatory Submissions and Support
With more than 30 years of global regulatory experience, Confidence Pharmaceutical Research expertly navigates the complexities of submission processes. Our in-house regulatory specialists work closely with 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, and Competent Authorities (including Ministries of Health)
- Schedule and support pre-submission meetings with FDA, EMA, and others
- End-to-End Submission Management
- Plan regulatory application process and discuss it with the sponsor before the submission, making sure that all required documents are in place, and the team is ready to meet tough deadlines
- Discuss potential risks and prepare risk-mitigation strategies
- Manage initial applications through final approvals
- Handle country-specific approval steps, like when a local ethics review is needed before a national one, or when two ethics committees must review
What Sets Us Apart?
- Regulatory specialists in each region ensure local compliance with global consistency
- Expertise across major regions—including the US, Canada, Latin America, Europe (EU and non‑EU), MENA, and APAC—with direct experience working with health authorities such as FDA, EMA, MHRA, and others
- Full-service support from startup documentation through post-approval compliance
- Flexible to each sponsor’s structure: centralized or decentralized regulatory models