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Summary of new EU Clinical Trial Regulation

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The changes the regulation brings companies need to already be reviewing their current processes, systems and supporting infrastructure for clinical trial applications and operations. They need to…

China UDI Requirements

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Unique device identifier refers to a series of codes constituted of numbers, letters and/or symbols and established on the basis of standards. Unique device identifier, which includes product iden…

Regulatory Success Automation

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You may think that regulatory automation is something that requires an intense technical infrastructure backed by a big budget to boot. But the truth is, even small businesses can use simple autom…

Medical Devices: Structured Content Authoring Saves Time & Reduces Cost

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Medical device companies creating technical documentation, clinical / post-marketing reports, labeling and quality documentation with increasing regulations and recent MDR/IVDR compliance in mind …

Avoiding Regulatory shortfalls in the Submission Path

Commercialization of new drugsrequire careful navigation through complex regulations defined by Global health authorities. Drug development process needs extensive collaborations with internal &am…