PumasAI - Strategic & Scientific Consulting Services

MIDD

Join our clients who saved upto $1B using MIDD by working with us
Avoid unnecessary studies, development bottlenecks and undue regulatory burden
Accelerate time to market, gain the best label your drug deserves

Novel Modalities

Work with us for your FIH, endpoint selection, trial design for mRNA, siRNA, Cell Therapy, rare disease products
Avoid jeopardizing your asset owing to limited experience
Leverage our team who helped multiple clients on novel modality programs

Regulatory Strategy

Team up with our seasoned regulatory experts on Pre-IND/BLA, EOP2, MIDD Meetings, FIH, Project Optimus, NDA/BLA
Avoid clinical holds, unwarranted large studies, multiple review cycles
Secure regulatory success with a lean development program

Clinical Pharmacology & Pharmacometrics

Work with us on all your PK, PD needs across drug development
Avoid unnecessary studies, multiple review cycles
Make timely internal decisions with confidence to drive regulatory success

Consulting Leadership

Amit Roy

Head, Scientific & Strategic Consulting

Vijay Ivaturi, PhD

Co-founder & Chief Scientific Officer

Beatriz Guglieri-López

Director, Clinical Pharmacology and Pharmacometrics

Jessica Wojciechowski, PhD

Director, Clinical Pharmacology & Pharmacometrics

Mike Tagen, PhD

Principal Scientist

Making a difference with our consulting capabilities

$1B

We save money and time
for our 60+ clients.

Successful regulatory submissions using Pumas products is ever-growing.

PumasAI worked with us with incredible flexibility and agility despite tight timelines and sometimes the need for re-work or additional evaluation, as often is the case with data driven exercises.

Samira Merali, PharmD, MS,
Sr. Director & Cardiovascular Therapeutic Head,

BMS