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Pharmaceutical Procurement Strategies Overview

Viseven

Hidden expenses can pile up, spiraling out of control due to many reasons related to supplier performance: the lack of appropriate documentation, storage, wrong dosage forms, and the list goes on. Technologies allow pharmaceutical companies to collect and analyze a massive amount of data to ensure proper drug safety.

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ICH Q13 and What Is Next for Continuous Manufacturing

ISPE

1 International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. This article highlights the overall benefits and scope of Q13, as well as what we see as the next set of opportunities to further expand the adoption of CM across the globe.

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Removing Regulatory Hurdles for Continuous Pharmaceutical Manufacturing

ISPE

This article discusses how US regulators addressed the regulatory hurdles related to CM to broaden its adoption through engagement, regulatory science, guidance, and international harmonization. 2 , 3 Key differences between CM of pharmaceuticals versus other chemicals relate primarily to volume and runtime.

FDA 52
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CMC Requirements for New Drug Registration in Latin America

ISPE

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

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Agile, Data-Driven Life Cycle Management for Continuous Manufacturing

ISPE

This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach to risk management can help CM achieve its full potential. In 2021, CONTINUUS Pharmaceuticals secured a$69.3