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August 12, 2020 Regulatory Affairs

505(b)(1) vs. 505(b)(2): Choosing the Appropriate Regulatory Pathway

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August 12, 2020 Pharmacovigilance

EMA Vaccine Applications for COVID-19 Explained

Breaking down the pathway for COVID-19 vaccines in Europe and how the…

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August 5, 2020 Regulatory Affairs

What You Need to Know About the ICH

Our experts are sharing details about the ICH, its purpose and history,…

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August 3, 2020 Life Science Consulting

Virtual GCP Auditing: Your Questions Answered!

Which assessments can be done remotely? How is privacy secured? How should…

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July 30, 2020 Life Science Consulting

Key Takeaways: New Draft Guidance on Cannabis and Clinical Research

On July 21st, the FDA released a draft guidance document for developers…

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July 28, 2020 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 23, 2020 Life Science Consulting

7 “Aha Moments” in Data Integrity

Elevate your Data Integrity program with these 7 expert tips for reliable…

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July 22, 2020 Regulatory Affairs

Understanding Bioequivalence and Product-Specific Guidances

Your guide to understanding product-specific guidances for generic drugs that are bioequivalent…

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July 20, 2020 Life Science Consulting

6 Quick Tips for Excel Spreadsheet Validation

Are you using Microsoft Excel spreadsheets for GxP activities? We're sharing six…

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