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November 22, 2019

Combination Products: The Top Three Regulatory Challenges

Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ have revealed some of our customers’ biggest challenges. This is the first of three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.
Shari Krusniak

Shari Krusniak

Director, Marketing, Contract Manufacturing & Integrated Solutions

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  • Previous Posts

    May 14, 2019

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    Lynn Yao

    West

    Leo Posner of Johnson & Johnson presenting at the PDA Combo Workshop

    April 03, 2019

    The Challenges of Combination Products

    Fran DeGrazio

    Fran DeGrazio

    VP, Technical Services and Scientific Affairs

    The SmartDose Platform in use

    August 10, 2018

    Combination Products - Why Design Verification Studies Are Needed

    Daniel Bantz

    Daniel Bantz

    Technical Manager, Packaging & Performance, Lab

    SmartDose Platform

    August 08, 2018

    Performance Testing: Strategies to Qualify Combination Products

    Page McAndrew

    T. Page McAndrew, Ph.D.

    Director, Scientific Communications, SA & TS

    Mixject Admixture System

    January 30, 2018

    Co-Packaged Combination Products – System vs Component

    Doug Hostetler

    Doug Hostetler

    Principle SME, Admin. Systems, TCS

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