Increase your Odds of Regulatory Success with a Quantitative and Regulatory Science-based Strategy
As drug development has become more complex, with a higher risk of failure, greater uncertainty, and increased expense, the need for a quantitative and regulatory science-based strategy becomes clear. The first step in performing a strategic assessment is a gap analysis and roadmap. Certara’s regulatory and clinical pharmacology experts evaluate the 40 different questions that the agency will ask about your clinical pharmacology data package at the time of a New Drug Application (NDA) submission. Thus, we can facilitate the evaluation of your drug program and address any potential gaps before you meet with the regulators at the end of Phase 1, Phase 2 or Pre-NDA. A gap analysis and clinical pharmacology development strategy ensures that all relevant domains are covered, gaps are properly addressed, all elements needed for informative actionable product labeling are clear, and that data is gathered at meaningful times to enhance decision-making during development.
Benefits at Any Stage of Development
For a target product or program, we will:
- Identify potential R&D or regulatory challenges, custom to the molecule, therapeutic area, and competitive landscape
- Integrate pre-clinical findings with planned clinical programs
- Create a clinical pharmacology development program in line with anticipated regulatory filing strategy
- Collect the right data and leverage model-informed drug development technologies to optimize the drug label
- Provide readiness support and help guide interactions with regulatory agencies for research programs and submittals
- Minimize post-marketing requirements
ROI of Gap Analysis and Strategic Roadmap
Our roadmap will prioritize needs, provide strategic direction, identify gaps, assess risk/benefits, position you for successful interactions with regulators and other partners, and create value. The strategic plan will be harmonized with your overall clinical development plan and considers strategies to support breakthrough therapy applications and accelerated versus regular approval pathways. In all scenarios, the gap analysis and strategic plan identifies and mitigates risks which could become either decision-making hurdles during development or regulatory hurdles at the time of approval. In our experience, the ROI for this analysis is 10-20x, and frequently 50-100x or more, depending on the program. The ROI includes reduced study sizes, expedited timelines, and studies that can be replaced by MIDD.
Contact us to learn how gap analysis can inform your strategic roadmap to increase your drug program’s likelihood of regulatory and commercial success.