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