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July 28, 2021 Regulatory Affairs

Understanding The Medical Device Single Audit Program

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July 27, 2021 Life Science Consulting

Meet the Expert: Dana Votin

We’re shining a spotlight on GCP expert Dana Votin. Learn how she…

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July 27, 2021 Life Science Consulting

Creating Efficiencies with Data Integrity

Over recent years relations with data and its weight have changed significantly;…

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July 22, 2021 Regulatory Affairs

The Human Factor – Preparing Your Device for Usability Testing

Usability studies that take the "human factor" into consideration are essential for…

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July 21, 2021 Life Science Consulting

Innovation and Rapid Growth: A Double-Edged Sword

With the breakthrough innovations we’re seeing in modern medicine, companies are facing…

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July 19, 2021 Life Science Consulting

FDA Guidance on Gene Therapy Products: RCR Testing and Monitoring...

Part four in our recent blog series related to FDA’s guidance document…

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July 15, 2021 Life Science Consulting

How to Ensure Your Workforce is GMP Compliant

Can you deliver what the Inspector expects? Ensure your team is GMP-ready…

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July 15, 2021 Life Science Consulting

Fundamentals of Data Integrity for ATMP Development

Advanced Therapy Medicinal Products (ATMPs), or Cell and Gene Therapies (CGT), have…

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July 12, 2021 Regulatory Affairs

Pedaling While Fixing a Flat: Conducting a Good FDA Meeting...

Before using a significant risk medical device in a clinical study, Sponsors…

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