Expert regulatory guidance for a faster path to drug product approval.
We support pharmaceutical and biotech innovators seeking product approvals in major global markets.
What products are you looking to bring to market?
We deliver deep real-world global regulatory affairs expertise and hands-on support for:
JOIN US FOR
2020 AAPS PharmSci 360
October 26 – November 3
Explore virtual sessions & schedule a 1-on-1 with the DataRevive team.
A full-service partner for the entire product development lifecycle.
President
Michele Dougherty, Ph.D.
- Formerly FDA CDER OBP Review Chief
- 17+ years of experience
Vice President Nonclinical
Julia Carrier, Ph.D.
- Formerly of Pfizer
- 18+ years in nonclinical PD, PK, and toxicology
Vice President CMC Small Molecule
Yong Wang, Ph.D.
- Formerly of FDA CDER
- 17+ years of experience
V.P of Clinical
H. Wayne Hutman, M.D.
- 20+ years in pharma industry
- Has conducted 100+ clinical trials
Regulatory & CMC Principal Consultant
Audrey Jia, M.D., Ph.D.
- Formerly of FDA CDER & Pfizer
- 20+ years of experience
Vice President CMC Biologics
Kathleen Retterson
- Formerly of Spectrum, Charles River, Genzyme & Amgen
- 30 years of experience in CMC/GMP
Make our specialists an extension of your team.
No other consulting firm maintains the depth and breadth of expertise that DataRevive has in-house. Tap it today!
Did You Know?
In one year, DataRevive completed 5 GMP pre-approval inspections for small molecule & biological products in Japan, China, Scandinavia, and the US.
May 7, 2020