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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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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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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Fundamentals of Data Integrity for ATMP Development
Advanced Therapy Medicinal Products (ATMPs) have the incredible potential to cure devastating…
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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In July 2018, FDA issued a draft guidance document entitled “Testing of…
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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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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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Medical Monitoring: Learning from the Past & Looking Ahead
As the complexity of clinical trial studies grows, new challenges to safety…
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