01. Mission Statement

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.

02. Covid-19
Strategies Plus
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.

A confident professional engaged in modeling and simulation using the sophisticated tools provided by Simulations Plus, Inc.
A confident professional engaged in modeling and simulation using the sophisticated tools provided by Simulations Plus, Inc.

Forecasting Future Pathways

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

Ready to get started?

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03. Experts
Meet the Experts
Sandra Suarez Sharp

Sandra Suarez Sharp

President
Regulatory Strategies Center of Excellence
Xavier Pepin

Xavier Pepin

Vice President, PBPK R&D
Physiologically Based Pharmacokinetics (PBPK) Solutions
04. TESTIMONIALS
What Customers Say

“For Biotech companies, finding strategic partnerships is a necessity in streamlining our development programs to save time and money. Simulations Plus nimbly partnered on a program to not only develop a PBPK model, but to also develop a DDI regulatory roadmap that informed our regulatory approach towards NDA filing and helped to design the next steps of our program. Their knowledge of the area and ease of partnering exceeded my expectations.”

Sr. Vice President, Pharmaceutical Sciences
05. Publications
Peer-reviewed publications

Authored by Regulatory Strategies Team

View all publications