Expert regulatory guidance for a faster path to drug product approval.

We support pharmaceutical and biotech innovators seeking product approvals in major global markets.

CMC

Guided by former
CMC regulators.

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Preclinical

From study design to
report writing & review.

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Clinical

To streamline the
path to approval.

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Post-Approval

Lifecycle strategies for
marketed products.

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What products are you looking to bring to market?

We deliver deep real-world global regulatory affairs expertise and hands-on support for:

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2020 AAPS PharmSci 360

October 26 – November 3
Explore virtual sessions & schedule a 1-on-1 with the DataRevive team.

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A full-service partner for the entire product development lifecycle.

Audrey Jia

GMP Inspection/ Regulatory Lead

Audrey Jia, M.D., Ph.D.

  • Formerly of FDA CDER & Pfizer
  • 20+ years of experience
Monica Hughes

Regulatory/Delivery Lead

Monica Hughes, M.S.

  • Formerly of FDA CDER
  • 17+ years of experience
Michele Dougherty

CMC Biological Team Lead

Michele Dougherty, Ph.D.

  • Formerly FDA CDER OBP Review Chief
  • 17+ years of experience

Yong Wang

CMC Small Molecule Team Lead

Yong Wang, Ph.D.

  • Formerly of FDA CDER
  • 17+ years of experience
Julia Carrier

Preclinical Team Lead

Julia Carrier, Ph.D.

  • Formerly of Pfizer
  • 18+ years in nonclinical PD, PK, and toxicology

Wayne Hutman

Clinical Team Lead

Wayne Hutman, M.D.

  • 20+ years in pharma industry
  • Has conducted 100+ clinical trials

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!

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5 Gmp Inspections
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.

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