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Life Science Consulting Blog Posts

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) have the incredible potential to cure devastating…

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June 16, 2021 Life Science Consulting

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

In July 2018, FDA issued a draft guidance document entitled “Testing of…

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June 14, 2021 Life Science Consulting

What to Expect From an FDA Inspection, Part 2

Are you prepared for a FDA inspection? In the final installment of…

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June 9, 2021 Life Science Consulting

United in Diversity: Six Tips for European Batch Release

Navigating the regulatory landscape can be challenging, but implementing these tips will…

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June 8, 2021 Life Science Consulting

Medical Monitoring: Learning from the Past & Looking Ahead

As the complexity of clinical trial studies grows, new challenges to safety…

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