• All analyses are preformed in validated environment and undergo senior scientific QC to ensure accurate and reliable results
  • Data formatted for NCA and further pharmacometric analysis, saving time and money on future modeling work
  • First in human studies, especially SAD/MAD, and other clinical pharmacology studies
    • Clinical bioequivalence
    • Dose proportionality
    • Drug-drug interactions
    • Food effects
    • Drug accumulation
  • Preclinical pharmacokinetics (PK) and Toxicokinetics (TK)

We Deliver!

  • Blazing-fast turnaround of preliminary interim results
  • Submission-ready full report or CSR sections
  • Complete set of tables, figures, and listings (TFLs)
  • All transport files (CDISC SDTM or SEND format)
    • SUPPP
    • PP
    • OC
  • Pharmacometric PK analysis-ready dataset

03. Experts
Meet the Experts
02. Testimonials
What our customers say

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

Sr Clinical Research Scientist

“Well executed and conducted. All my questions were answered in real time and I very much appreciated that. The staff were very knowledgeable and approachable.”

Clinical Pharmacologist

“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

“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

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

Top 10 Pharma

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

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