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December 2, 2021 Clinical Research Solutions

7 Benefits of Working with a Biostatistician

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December 1, 2021 Medical Information

Product Launch Preparation: Medical Information Response Documents

Proper planning and oversight can help ensure your team has medical information…

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November 22, 2021 Life Science Consulting

How to Select the “Right” CMO Partner

There are many ways in which you can evaluate a Contract Manufacturing…

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November 9, 2021 Life Science Consulting

A Roadmap for Clinical Trials: QP Certification of IMP

An understanding of the complex and various regulation across multiple European regulatory…

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November 8, 2021 Life Science Consulting

eQMS: Your Questions, Answered

Enterprise Quality Management System (eQMS): Simple answers to some complex questions

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November 5, 2021 Agency Alerts

EMA to Marketing Authorization Holders (MAHs): Submit Type I Variations...

On Friday, October 29, 2021, the EMA published a statement providing marketing…

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November 1, 2021 Life Science Consulting

How to Adopt an eQMS in 3 Simple Steps

A recent survey showed that 33% of the organizations surveyed use paper…

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November 1, 2021 Regulatory Sciences

FDA’s Expedited Programs Explained

In order to incentivize the development of therapies (drugs biologics) to fill…

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