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Life Sciences Blog

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eCTD Publishing: 10 Tips for a Smooth Submission Process

Over the past few decades, the pharmaceutical industry has seen a dramatic shift in how regulatory submissions are handled. Gone are the days of...
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Mastering EU Product Information: The Role of the EMA’s Linguistic Review Process in Centralised Procedures

For Medicinal Products, the Product Information (PI) is a key document that provides a summary of officially approved information for Healthcare...
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MHRA to Launch RegulatoryConnect Portal in the UK: A New Era in Regulatory Management 

During a webinar held on March 12, 2024, they unveiled the features of Release 1 of this innovative portal, previously known as the “RMS” or “Regulatory...
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UK’s medicines regulator announces IT roadmap

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently implemented a new organisational structure which aims to meet the additional...
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