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February 24, 2021 Regulatory Affairs

Meet the Expert: Colin Wheeler

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February 22, 2021 Life Science Consulting

Uncover Opportunities for Improvement with an Annual Product Review

Annual Product Reviews (APR) create an opportunity to analyze your product’s characteristics,…

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February 18, 2021 Regulatory Affairs

Brexit: New Regulatory Opportunities in the United Kingdom

As the dust settles on the final Brexit deal, the UK’s Medicines…

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February 17, 2021 Life Science Consulting

Meet the Expert: Ewelina Czerniec-Michalik

Meet Ewelina Czerniec-Michalik, a member of our team supporting clients with nitrosamine…

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February 17, 2021 Regulatory Affairs

How to Maximize the Value of Cell and Gene Therapy...

Product development is an extremely time consuming and challenging process for any…

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February 16, 2021 Regulatory Affairs

Overcoming High-Risk Situations and Tight Deadlines: How to Successfully Complete...

Much like buying a home as an individual, a company contemplating the…

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February 12, 2021 Regulatory Affairs

How GDUFA II Impacts the Timing and Approval Process for...

Facing several regulatory challenges related to the review of abbreviated new drug…

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February 10, 2021 Life Science Consulting

12 Critical Questions and Answers for a Successful Tech Transfer

Now, more than ever, companies are transferring products and processes from one…

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February 10, 2021 Life Science Consulting

Three Steps Towards Complying with Nitrosamine Regulations

How a results-driven, chemistry-based strategy will enable companies to meet MAH responsibilities…

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