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
03. Experts
Meet the Experts
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