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, modelling 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)

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