Regulatory Consulting

Synchrogenix Provides Global Regulatory Strategy Consulting, Harnessing All of Certara’s Capabilities and Leveraging Our Technologies and Domain Expertise

  • Regulatory gap analysis of development programs and global dossiers to increase probability of success for approval and patient access
  • Agency engagement preparation, communications, and leadership
  • Review of Agency correspondence, analysis of relevant regulatory guidelines and precedent
  • Competitor labeling assessment to identify opportunities for competitive differentiation; labeling preparation and negotiations
  • Proactive stakeholder consultation to achieve alignment
  • Modification of development plans to incorporate Agency advice, including innovative approaches to address divergent regional perspectives or requirements
  • Consideration of expedited regulatory pathways
  • Integration of health economics outcomes research (HEOR), risk mitigation, modeling and simulation approaches, and post-authorization activities into drug development and regulatory strategies
  • Due diligence assessments for in-licensing and partnering, including proposals to increase value proposition
  • Applications; dossier preparation; and submission leadership
  • Incorporation of regional regulatory requirements (United States, European Union, Asia-Pacific, Latin America)

Achieving Regulatory Milestones

Having a well-constructed regulatory submission strategy that is interwoven into a sponsor’s operational program is even more critical to achieving success than in the past. Between the escalating competition, speed, cost, and risk; benefit pressures on sponsors; the need for payers to see “best-in-value” data of a drug to justify adding it to the formulary; new global regulatory expectations for electronic submissions; or the complexity of the drug itself—strategy is key.

With more than 30 years of experience and a team of 250 scientific regulatory professionals working with sponsors to achieve global regulatory milestones, Synchrogenix focuses on the strategy first, and then maps an efficient and effective operational plan. By involving us as a strategic partner—as early as identification of a lead candidate through life cycle management—we ask the right questions during front end meetings, and working together with our Certara colleagues, assess the right processes, tools, and resources to achieve all goals.

Regulatory Science Meets Model-informed Drug Development

While model-informed drug development (MIDD) is increasingly being requested by global regulators, articulating this approach is both an art and a science. It starts with asking the right questions, creating the justification based on pre-clinical data and the strength of the model, and culminates in regulatory approval. In addition, successfully employing MIDD requires addressing specific challenges in each therapeutic area while satisfying the sponsor’s overall business objectives and constraints. Meeting these challenges requires strategic regulatory direction and writing, a thorough understanding of modeling and simulation, as well as traditional clinical development, and an understanding of the program’s constraints and the regulators’ current positions.

Leveraging Modeling and Simulation (M&S) and Regulatory Science to Optimize Core R&D Decisions

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