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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?

  • Define submission pathways aligned with local agency processes and approval sequencing
  • Evaluate regulatory feasibility during study startup to plan for roadblocks early
  • Provide region-specific process flows, checklists, and timeline expectations
  • Manage documentation including PI certifications, import/export permits, and site contracts
  • Act as liaison with Ethics Committees, IRBs, Competent Authorities, and Ministries of Health
  • Schedule and support pre-submission meetings with FDA, EMA, and others
  • Handle initial applications through final approvals
  • Adapt processes for local-before-national, dual ECs, or country-specific nuances

What Sets Us Apart?

Ready to discuss your Clinical Trial needs?

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