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Blog

Implementing USP Visual Inspection Requirements

By Eamonn Vize, November 21, 2017

The word “visible” in the expression, Visual Inspection of Parenteral Products, has no meaning unless the viewing conditions are specified. 

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Are You Ready? Major Changes Coming to Europe MDR and IVDR

By John Henchion, September 28, 2017

Introduction: One of the major focuses this year at the RAPs Convergence in DC was implementation timelines for the EU Medical Device Directive and the In Vitro Device Regulations.

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Where to Draw the Line?

By John Henchion, September 11, 2017

What is an appropriate level of GMPs for a supplier manufacturing site?

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Optimizing Time to Market

By David Shenberger, June 20, 2017

In the biotech industry today, mergers, acquisitions, and joint ventures are announced daily. Startup companies with viable molecules must decide early how they are going to get a drug into trials and eventually to the marketplace as rapidly as possible. Contract research organizations (CROs), contract development and manufacturing companies (CDMOs), and dedicated contract manufacturing organizations (CMOs) all offer options for the specific expertise needed to complete the research, product development, and process development necessary to successfully manufacture a new drug entity.

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How to Understand ASTM E2500