With 30 years of experience in this field, Confidence has developed the expertise to work in many regions across the world by relying exclusively on local regulatory specialists who are familiar with the intricacies of local regulations and can expedite the approval process. We also have expertise in FDA approvals (pre-submission meetings, submissions) and European approvals (UK, EU and non-EU countries).
Navigating the regulatory approval process can be complex and pose several challenges. During the feasibility stage, the regulatory specialist evaluates whether the study is suitable for the local jurisdiction and subsequently provides a comprehensive list of necessary documents, a process workflow, and an official timeframe based on local experience.
Acquiring regulatory approval for clinical studies is crucial, and understanding the local regulatory requirements is of utmost importance. Each country has a unique regulatory pathway and timeline, which varies significantly.
For instance, certain countries require both national and local Ethics Committees/Institutional Review Board (IRB) approvals, while others mandate local approvals before national submission. Some countries mandate that fully-executed site agreements be obtained before submission to the Competent Authorities, while others require such agreements before actual approval is granted. The regulatory landscape also includes requirements for import and export licenses, local insurance, principal investigators’ certification, and much more.