Regulatory Strategies for FDA and EMA Compliance
Developing a successful drug requires more than a great idea. You also need a clear and effective regulatory strategy that addresses the needs of investors, regulatory agencies, and your development team.
Regulatory and Commercial Success Starts Here
Regulatory strategies dictate a drug’s development trajectory and influence the time, resources, and data required for approval. While the fundamental regulatory principles are globally consistent, the major challenge lies in meeting specific regulatory requirements for each region.
At Cytel, we avoid the checkbox-ticking approach. We work with you collaboratively to build strategies, embracing an iterative process, and, when needed, seamlessly integrating other specialists.
Contact usLower costs
We tailor regulatory strategies to significantly reduce unnecessary expenditure, streamlining resource allocation for optimal financial efficiency.
Increased probability of success
Our strategic regulatory planning boosts drug approval rates by aligning your development efforts with specific regulatory expectations.
Shorter timelines
Strategic regulatory planning boosts drug approval rates by aligning development efforts with specific regulatory expectations.
Improved decision-making
Our collaborative and iterative strategy development enhances decision-making quality, for better navigation through regulatory landscapes.
Regulatory Roadmap: Build Value and Pave the Way to Market Success
A regulatory roadmap, essential for navigating the drug’s route to market, is invaluable for managing relations with stakeholders such as investors and partners and enhancing project value. We tailor your roadmap to your specific stakeholder needs, offering strategic direction on regulatory strategies, expedited pathways, communication plans with authorities, pediatric studies, and the nuances of conditional or accelerated approvals.
Supporting Agency Meetings from Preparation to Follow-Up
Discussions with regulatory agencies can be requested at any time during the development process. At Cytel, we provide comprehensive support to help you engage with regulatory agencies, from selecting the right agency and timing to leading meetings and interpreting responses for strategic next steps.
Pediatric Regulatory Planning and Strategy Services
Our pediatric regulatory services are tailored to guide you through the complex process of pediatric study planning and execution. We specialize in creating integrated Pediatric Study Plans (iPSP) for the US and Pediatric Investigation Plans (PIP) for the EU, ensuring comprehensive strategy and preparation.
Our expertise includes effective communication with regulatory authorities and navigating the specific requirements and considerations unique to pediatric development, including waivers and deferrals based on disease prevalence and pediatric relevance. We assist from the initial evaluation through planning and submission, helping you effectively meet all pediatric regulatory requirements.
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Webinar on First-in-Human Trials
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45%
Of novel drugs granted Fast Track status in 2023
16%
Of novel drugs designated as breakthrough therapies in 2023
56%
Of novel drugs designated Priority Review in 2023
16%
Of novel drugs approved under the Accelerated Approval pathway
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