In today’s competitive pharmaceutical and combination device landscape, evidence is more than just a regulatory requirement—it is a strategic asset. Systematic Literature Reviews (SLRs) are an important component of regulatory submissions that shape clinical development strategies, inform lifecycle management, and guide cross-functional business objectives. Companies that understand and leverage SLRs to their fullest extent can accelerate development timelines and maximize the impact of their evidence generation efforts.
What Is an SLR and Why Does It Matter?
An SLR is a structured and comprehensive approach to identifying, appraising, and synthesizing all available evidence relevant to a specific research or clinical question. Unlike narrative reviews, which may be selective and prone to bias, SLRs follow a transparent, reproducible methodology that enhances the credibility and defensibility of findings. For pharmaceutical companies, this rigor is critical to:
- Meeting regulatory expectations from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
- Supporting internal decision-making across R&D, Clinical, Medical Affairs, and Commercial teams.
- Demonstrating compliance with Good Clinical Practice (GCP) and evidence standards.
According to the FDA’s guidance on clinical evidence, systematic and comprehensive reviews of existing data are foundational for submissions, especially in areas such as safety evaluations, clinical study design, and real-world evidence integration [FDA Guidance, 2023].
Strategic Applications of SLRs Across the Product Lifecycle
- Regulatory Submissions
- At the core, SLRs provide the evidence base required for regulatory dossiers, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs). By ensuring that all relevant data is systematically captured and analyzed, SLRs:
- Reduce the risk of oversight or omission during submission.
- Strengthen the defensibility of claims made in clinical and safety sections.
- Align with EMA and FDA requirements for transparency and reproducibility.
- At the core, SLRs provide the evidence base required for regulatory dossiers, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs). By ensuring that all relevant data is systematically captured and analyzed, SLRs:
- Early-Stage Development and Clinical Planning
- SLRs are not just for late-stage submissions. In early development, they:
- Identify unmet medical needs and gaps in existing therapies.
- Guide protocol design by highlighting validated endpoints, comparator treatments, and patient populations.
- Inform go/no-go decisions for pipeline candidates, helping organizations allocate resources effectively.
- For example, in oncology drug development, comprehensive SLRs of biomarkers and patient-reported outcomes can help shape both trial design and regulatory strategy [EMA Oncology Guidance].
- SLRs are not just for late-stage submissions. In early development, they:
- Lifecycle Management
- Post-approval, SLRs support ongoing safety monitoring, market differentiation, and new indication expansion. They:
- Track emerging safety signals through continuous surveillance.
- Identify opportunities for label expansions or combination therapies.
- Provide evidence for health technology assessments (HTAs) and reimbursement negotiations.
- Post-approval, SLRs support ongoing safety monitoring, market differentiation, and new indication expansion. They:
Aligning SLRs With Business Objectives
The true strategic value of an SLR lies in its ability to serve multiple stakeholders simultaneously:
- R&D Teams gain clarity on the competitive landscape and emerging technologies.
- Clinical Teams design smarter trials with a more astute understanding of the required endpoints to maximize opportunities for market launch.
- Medical Affairs leverage insights to support scientific communications and KOL engagement.
- Commercial Teams access robust evidence to inform market positioning and value messaging.
By aligning SLR efforts across functions, organizations can reduce duplication, optimize spend, and increase the return on evidence generation.
When to Bring in the Experts
While many organizations attempt to conduct SLRs internally, the level of rigor, transparency, and regulatory alignment required often exceeds available resources. Partnering with an experienced team such as Criterion Edge can:
- Ensure methodological rigor and compliance with PRISMA and other international standards.
- Deliver submission-ready outputs that meet FDA, EMA, and other global authority expectations.
- Free internal teams to focus on strategic decision-making rather than time-consuming evidence synthesis.
Outsourcing can be especially valuable when timelines are compressed, in areas requiring niche subject matter expertise, or when preparing for high-stakes submissions.
Conclusion
Systematic Literature Reviews are far more than regulatory box-checking exercises. They are strategic tools that can accelerate drug development, strengthen regulatory submissions, and maximize the commercial impact of new therapies. By leveraging SLRs effectively, pharmaceutical and combination device companies can align regulatory and business objectives, reduce redundancy, and ultimately bring safe and effective products to patients faster.
For organizations seeking to unlock the full value of SLRs, Criterion Edge brings decades of expertise in scientific and regulatory writing, supported by a proven track record of delivering high-quality, submission-ready outputs.
Interested in learning more? Contact Criterion Edge to speak with an expert and explore how systematic literature reviews can strengthen your regulatory and business strategies.
