If you’re working on a submission for the FDA, IRB, or another regulatory body, you already know that evidence matters. But not just any evidence will do.

A regulatory literature review isn’t just a list of sources; it’s a curated, compliance-focused synthesis that supports your product, process, or protocol.

What Sets Regulatory Reviews Apart?

Compared to academic or exploratory reviews, regulatory literature reviews need to:

• Align with specific standards or submission requirements
• Focus on safety, efficacy, or ethical justification
• Include audit-ready documentation
• Use transparent and reproducible methods

Missing these elements can result in delays, rejections, or legal exposure.

What to Include

• Targeted search strategy: Clearly defined terms and database selection
• Inclusion/exclusion criteria: Based on relevance to regulatory endpoints
• Evidence tables: Summarizing key data (e.g., dosage, outcomes, adverse effects)
• Critical appraisal: Assessment of study quality and relevance
• Full documentation: Search strategy logs, PRISMA flow diagrams, reference lists

What to Leave Out

• Overly broad or irrelevant studies: These muddy your message
• Duplicate references: Can lead to confusion or scrutiny
• Unsupported claims: Everything must be evidence-based and traceable

Working on a regulatory submission? MedSearch Solutions delivers literature reviews that meet compliance standards and reduce review risks. Let’s talk about your project.

The Value of Getting It Right

High-quality regulatory reviews can:

• Speed up approval timelines
• Strengthen the credibility of your application
• Support compliance with ethical and legal standards
• Build confidence with reviewers and stakeholders

At MedSearch Solutions, we bring expertise in both regulatory language and rigorous evidence synthesis. Whether you’re submitting to the FDA or preparing an IRB protocol, we help ensure your review supports your success.

📩 Need expert support? Contact us today.