Global Regulatory Strategies

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De-Risk Regulatory Submissions with the Simulations Plus Team

All major regulatory agencies around the world, including the FDA, EMA, PMDA, ANVISA, & NMPA have licenses to GastroPlus®, with reviewers in all agencies trained on the program.

Forecasting Future Pathways

Sandra Suarez-Sharp, a 20-year FDA Master Reviewer recently joined Simulations Plus to lead the Regulatory Strategies team supporting companies with their interactions with global health authorities.

Dr. Suarez-Sharp received her Ph.D. from the University of Florida and spent two years as a postdoctoral fellow at the University of North Carolina (Chapel Hill) before joining the U.S. FDA in 1999. She spent time as a reviewer in the Office of Clinical Pharmacology, Office of Generic Drugs, and Office of Pharmaceutical Quality, where she most recently served as Master Reviewer and Scientific Advisor for the Division of Biopharmaceutics. She was actively involved in the development of many internal procedures for FDA reviewers and guidance documents for industry, and she is recognized as one of the preeminent thought leaders for Physiologically Based Biopharmaceutics Modeling (PBBM). Her experiences reviewing numerous applications across several offices at the FDA provide her a unique perspective from which your company may now benefit.

StrategiesPlus™ Mission Statement

StrategiesPlus™ provides our clients with superior submission strategies with regulatory oversight that:

  • Meet the requirements of global regulatory affairs and compliance to balance risk (de-risk assessment)
  • Ensure patient-centric drug product development/quality and reduce the number of information requests (IRs) resulting in accelerated drug product development and more affordable medicines

Submit with Confidence

Our goal is to help our clients minimize or eliminate the questions posed by regulatory reviews while decreasing the cost and time it takes to develop detailed reports. The Regulatory Strategies team analysis plans and reports help anyone – understand what was done and why… which reduces the need for rework and streamlines speed to market.

The Simulations Plus Regulatory Strategies team provides:

  • COMPREHENSIVE navigation through the complex global regulatory arena with clear strategic objectives and planning
  • DEVELOPMENT, REFINEMENT, & VALIDATION of PBPK and PBBM models to support biowaivers
  • DEVELOPMENT & VALIDATION of IVIVC/IVIVR to support clinically relevant drug product specifications
  • ESTABLISHMENT of safe space to gain flexibility in regulatory assessment
  • INTEGRATED support and training for your R&D teams
  • EXPERT liaison to facilitate interactions with regulatory agencies – meetings, conference calls, answers for regulatory questions

For more information, email regulatory@simulations-plus.com.