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May 4, 2021 Regulatory Affairs

Meet the Expert: Carrie Rabe

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April 28, 2021 Regulatory Affairs

Checklist for Building a Successful Risk Evaluation and Mitigation Strategy...

Are you required to implement a REMS program for your new product?…

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April 26, 2021 Life Science Consulting

Understanding Responsible Person and Wholesaler Dealers Authorization

During distribution, how can you maintain product quality and ensure product security?…

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April 20, 2021 Life Science Consulting

Meet the Expert: Gary Hyde

Our “Meet the Expert” series introduces you to our team of experts…

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April 19, 2021 Regulatory Affairs

The Anniversary We Didn’t Want: One Year of COVID-19 Milestones

We've seen both challenges and breakthroughs related to the development of novel…

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April 13, 2021 Life Science Consulting

Project Management and a Successful Reduction in Investigations Backlog: The...

Many of us have been faced with this beast that needs taming:…

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April 7, 2021 Regulatory Affairs

Understanding FDA Pre-ANDA Meetings

Pre-ANDA meetings speed up the development of generics through early engagement with…

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April 5, 2021 Life Science Consulting

5 Steps to CMO Identification and Selection for Cell and...

After assuring clinical validity, finding and managing the right contract manufacturing organizations…

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March 24, 2021 Regulatory Affairs

The Unique Challenges of Gaining Approval for Drug-Device Combos

There are many challenges to getting a drug-device combination approved by the…

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