Pumas-AI Consulting Services

Who We Are

Pumas-AI offers PK, PKPD, Modeling & Simulation and Clinical Pharmacology services to help you make informed decisions in the drug development process. The consulting team is powered by top notch drug development, regulatory and scientific experts possessing hands-on and in-depth experience across 400+ New Drug Applications (NDAs) and Biologic Licensing Applications (BLAs).

What We Do

Pumas-AI is committed to timely, high-quality PK, PKPD, Modeling & Simulation and Clinical Pharmacology projects to accelerate drug development and personalize patient care. We will work with you to increase the efficiency and certainty of your development programs.

Services

PKPD
  • Non-Compartmental Analysis (NCA)
  • Compartmental Modeling
  • Bioequivalence, IVIVC
Modeling and Simulation
  • Exposure Response Modeling
  • Clinical Trial Simulations
  • Interim Analysis
Regulatory Submissions
  • PKPD Data & Reports
  • EOP2 Meetings
  • MIDD Meetings
Product Development Strategy
  • Types of Studies Required and Timing
  • Shortest Path to Approval
  • Registration Strategy, Including Unprecedented Pathways

Team Experience

Clinical Pharmacology
  • Design & Analysis of FIH, SAD, MAD Studies
  • Design & Analysis of Renal/Hepatic Impairment, Drug-Drug Interaction, Food-Effect, Pediatric Studies
  • Design & Analysis of (Through) QT Studies
Pharmacometics
  • Population PK Analysis
  • Exposure-Response Analysis
  • Clinical Trial Simulations for supporting target attainment, dose selection, evidence of effectiveness, selection of dose, endpoints, adaptive design
Drug Development & Regulatory Strategies
  • Experience with 400+ NDA/BLAs across all therapeutic areas
  • Contributed to key Clinical Pharmacology & Pharmacometrics Regulatory Guidances & Policies
IT Infrastructure
  • State of the art computational system
  • Qualified environment with SOPs
  • Software such as NONMEM, R, Julia & Pumas
Regulatory Submissions
  • Meeting packages: Pre-IND, MIDD, NDA/BLA, Pediatric Plans, EOP2, Advisory Committee Meeting packages
  • Programs & Data submissions
  • Formal Dispute Resolutions, Labeling negotiations
Team Applications
  • Dashboards to share complex information to governance teams
  • Computational optimization
  • Custom reporting tools

Contact Us

Pumas-AI aims to provide the service excellence that you expect and is dedicated to your success. Our team will work to identify your needs, provide proactive insights and ensure the best possible outcome. Contact us to learn how we can create the right results together.

We look forward to collaborating with you!

Reach out to us at consulting@pumas.ai