Sandra Suarez-Sharp

Vice President, Regulatory Affairs @Simulations Plus, Inc.

My 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 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 To learn more visit: