Choose the right partner who can deliver on your business goals

Global regulators are increasingly requesting model-informed drug development (MIDD).  Meeting this challenge 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.

Our Regulatory Submission Strategy team of experts provides regulatory strategy, consulting, and submissions support for drug or device development projects from pre-clinical to late-stage,post-marketing. Certara’s integrated team consists of nonclinical, clinical, CMC, and regulatory experts.

Avoid common issues that can lead to rejections by partnering with experts who can quickly respond to changes in global regulatory requirements and mandates, keeping your submissions on track.  Ensure efficient, timely submissions through leading software and services that break down barriers between strategy, dossier development and global transmissions.

Our specialties are creating innovative and efficient regulatory strategies for drug development that include a wide range of therapeutic areas and types of programs (e.g., 505(b)(2), New Chemical Entity (NCE), biologics and biosimilars, expedited programs, regulatory agency meetings, responses to regulatory agencies, and regulatory submissions [INDs, IMPDs, NDAs/BLAs/MAAs]).

Confidently achieve regulatory milestones

Our solutions to expedite your approvals include:

  • Investigational and marketing application submissions
  • Lifecycle maintenance submissions
  • Master file submissions
  • Dossier management
  • S. agent services
  • Electronic transmission
  • Regulatory affairs
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Leverage a robust submission strategy

We have proven frameworks and processes to craft the best strategy to meet your needs.

  • Gap analysis of development programs, global dossiers and regulatory agency correspondence to increase probability of success for approval and patient access
  • Consideration of expedited regulatory pathways
  • Due diligence assessments for in-licensing and partnering, including proposals to increase value proposition
  • Global submission preparation and leadership focused on incorporation of regional regulatory requirements
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Expert communication and collaboration are essential

Our strategists have decades of experience successfully engaging with regulatory agencies and key stakeholders

  • Agency engagement preparation, communications and leadership
  • Labeling consultation, preparation and negotiations with regulatory agencies
  • Proactive stakeholder consultation to achieve alignment
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Elaine Taylor Vice President, Regulatory Strategy and Policy

Elaine has extensive regulatory experience and specializes in innovative and efficient regulatory strategies for drug development, including 505(b)(2) programs, regulatory agency meetings, responses to regulatory agencies, INDs, and NDAs/BLAs/MAAs.  Previously, she was at Syneos Health and Camargo Pharmaceutical Services.