Regulators are clear: modern drug development should rely less on empirical trial-and-error and more on integrated, mechanistic evidence. Model-informed drug development (MIDD) and new approach methodologies (NAMs) are no longer aspirational—they are expected.

We can help you operationalize these expectations. Our scientists combine regulatory-aligned modeling frameworks, AI-enabled platforms, and deep therapeutic experience to support confident decisions from early planning through submission and post-marketing commitments.

The outcome is stronger scientific justification, fewer unnecessary studies, and a clearer return on development investment.

A confident Simulations Plus scientist wearing a lab coat with Career Center emblem crosses arms.
Proven Scientific Partnership

“Simulations Plus had to bypass several key planning steps in order to complete a most unpredictable deliverable under a very aggressive timeline. Still, your team’s “all hands-on deck” approach brought us to what I would consider the best position we could possibly make for ourselves on this program, and the whip cream on top is a trusted team of consultants with the exact background we need to field future questions from FDA. I couldn’t ask for more.”

Sr Clinical Research Scientist

“Considering that this was an atypical project into which you were introduced at the last minute with less-than-ideal datasets, I’m actually very impressed with the outcomes…”

Sr Clinical Research Scientist

“Thanks so much for joining the call. I think your feedback was extremely valuable, and gave fresh perspective and ideas for the team. Really appreciate your time and expertise, especially with a project that’s been particularly perplexing to our team.”

Sr Clinical Research Scientist

“You guys are the best. Always two steps ahead of me!!”

Sr Clinical Research Scientist

“It has been an absolute pleasure working with the team – your efforts to build population and absorption models for our program with a mass of random data and extremely aggressive timelines were nothing short of impressive–they’re a testament to your high standards for quality and customer service.”

Sr Clinical Research Scientist

“Thanks so much for your super-responsiveness!!”

Sr Clinical Research Scientist

“Your analysis is very clear and most highly appreciated, as well as your exceptional responsiveness, and thorough work on the valuation of the hypothesis.”

Senior Vice President, Clinical Development

“We were very impressed with the details and clear explanations provided in the Statistical Analysis Plan.”

Top 10 Pharma

“I just noticed the discount offered due to the non-profit status of our organization and I wanted to say how much we appreciate this. Thank you for extending this discount to us.”

Non-Profit Organization
Consulting Services
  • PBPK & PBBM Consulting

    Supporting MIDD and NAM-Based Strategies

    Our PBPK and PBBM experts use GastroPlus®, the industry’s most trusted platform, to generate mechanistic, regulator-ready evidence that can replace or reinforce clinical and nonclinical studies.

    We help you:

    • Inform first-in-human dose selection and special population strategies
    • Predict food effects, drug–drug interactions (DDIs), and tissue exposure
    • Translate in vitro data to in vivo outcomes (IVIVE, IVIVC)
    • Reduce reliance on animal studies through mechanistic modeling
    • Support biowaivers, virtual bioequivalence, and QbD-driven formulation decisions

    Discuss My Project

  • QSP & QST Consulting

    Mechanistic Insight to De-Risk Clinical Decisions

    Our QSP and QST services align with regulatory emphasis on seen-to-believed biology—integrating disease mechanisms, pharmacology, and clinical data to support evidence-based decision-making.

    We help you:

    • Optimize dosing paradigms, endpoints, and trial design
    • Integrate preclinical and clinical datasets to explain observed responses
    • Identify responsive patient subpopulations to improve trial efficiency
    • Evaluate combination therapies, sequencing, and treatment holidays
    • Prioritize targets and compounds using systems-level evidence

    Discuss My Project

  • Pharmacometrics & Clinical Pharmacology

    Regulatory-Ready MIDD Execution

    Our pharmacometricians and clinical pharmacologists provide end-to-end MIDD support aligned with FDA expectations for model credibility, transparency, and impact on decision-making.

    We support:

    Discuss My Project

Built for the Future of Regulatory Science

Whether you are engaging regulators early or strengthening a submission, we can help you align with where regulatory science is going. Our services are tightly integrated with AI-driven, cloud-enabled platforms—allowing rapid iteration, traceable assumptions, and scalable analysis, which reduces uncertainty, minimizes unnecessary studies, and accelerates approval with confidence.

A woman in a business suit smiles confidently, representing Simulations Plus modeling and consulting.