When you’re preparing a submission to a regulatory body like the FDA or an IRB, the stakes are high. Your evidence isn’t just background support—it’s the foundation of your case.

But what exactly do reviewers want to see? And how can you make sure your submission stands up to scrutiny?

What Makes Evidence “Regulatory-Ready”

Regulatory reviewers expect your documentation to be:

• Relevant – Directly tied to your claims or protocol
• Transparent – Methods are clear and reproducible
• Traceable – Sources are cited, logged, and accessible
• Compliant – Aligned with applicable guidelines and standards

This applies to both the content and the format of your literature review.

Avoid These Common Pitfalls

• Cherry-picked studies without clear inclusion/exclusion criteria
• Missing documentation of search terms or databases used
• Outdated sources or citations in inconsistent formats
• Lack of critical appraisal or study quality assessment

Even strong evidence can be dismissed if the review process isn’t properly documented.

Working on a regulatory submission? MedSearch Solutions helps ensure your evidence is robust, traceable, and aligned with current standards. Reach out for a quick consult.

What to Include in Your Review

• A clearly defined objective
• Detailed search strategy and documentation
• Summary tables with key outcomes and study quality
• Clear rationale for included and excluded studies
• Consistent formatting and citation style

Your review should not only support your submission but stand on its own as a credible piece of evidence.

At MedSearch Solutions, we understand both the scientific and compliance aspects of regulatory documentation. Our evidence reviews are built to inform, persuade, and withstand scrutiny.

Need support? Let’s talk about your next submission.