Whitepapers , Regulatory Affairs

A Road Map To Expedited Review Pathways

7 July 2025
Overview

Accelerated development and manufacturing timelines provide developers with paths to move new therapies to market quickly while still maintaining a balance of risk/benefit assessment for patients. 

Regulatory agencies around the world, including the U.S. FDA, EU EMA, Health Canada, Japan PMDA, Chinese NMPA, and Brazilian ANVISA, offer expedited approval pathways that are applicable when new products are filling unmet medical needs for certain targeted diseases or conditions

Learn more about how Quotient Sciences helps customers navigate the development pathway, meeting the regulatory requirements of a product granted expedited development and review, as well as generating data needed to support drug approval.

 

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Date
7 July 2025
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Robert Cornog

Senior Director, Product Development

Robert Cornog has over 26 years of experience in product development and process design, across a broad range of dosage forms and ...

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Brad Rowe

Senior Director, Integrated Development

Brad Rowe joined the organization in 2005 and is based from our Philadelphia, PA sites in Garnet Valley and Boothwyn. He joined QS...

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Jamie Weishaar

VP, Global Commercial Drug Product

Jamie Weishaar is an experienced business development executive leader specializing in pharmaceutical drug development, including ...

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Jeff Folks

Senior Director, Business Development

Jeff Folks is an experienced business development leader specializing in pharmaceutical drug product development. At Quotient Scie...

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