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

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


Guided by former
CMC regulators.

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From study design to
report writing & review.

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To streamline the
path to approval.

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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:

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

Michele Dougherty


Michele Dougherty, Ph.D.

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

Julia Carrier

Vice President Nonclinical

Julia Carrier, Ph.D.

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

Kathleen Retterson

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!

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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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May 1, 2020

Resuming Business Operations Following the COVID-19 Pandemic: Part Two

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May 7, 2020

Avoiding and Reacting To Human Tissue, Cell And Gene Therapy Enforcement Actions: Communication Is Key

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