We like to keep our readers up to date on complex regulatory issues, the latest industry trends and updated guidelines to help you to solve a problem or make an informed decision.
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The SoHO Regulation: A Step Forward in European Health and Safety
The European Union has recently introduced a landmark regulation aimed at enhancing the safety, quality, and accessibility of substances of…
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New policy opens China biotechnology sector
In a recent move to foster innovation and high-quality development within China’s medical sector, Ministry of Commerce and National Health…
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Unlocking the potential benefits of Live Biotherapeutic Products (LBPs) for the treatment of bacterial vaginosis…
Introduction Bacterial vaginosis (BV) BV is a common vaginal condition characterised by odorous grey vaginal discharge which can be really…
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Navigating the New FDA Draft Guidance on Platform Technologies: An Overview for Life Sciences Companies
As regulatory landscapes evolve, staying ahead of new guidelines is crucial for life sciences companies. On May 29, 2024, the…
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De-risk Clinical Trials by Starting with Patient Insights and their Integration
Have you ever asked yourself how, as a patient, you would react if your physician proposed you to participate in…
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Overcoming the key hurdles in the development of Phage Medicinal Products
We have seen in the first part of our Phage therapeutics Series that Phages, these viruses that can infect and provoke…
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Accelerating Innovation: FDA Expedited Programs 101
In the fast-paced world of biotech innovation, time is of the essence. For European biotech ventures eyeing entry into the…
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Achieve Success for Your First US Product Application – Pathway to IND
Embarking on the journey to expand into the United States market is a pivotal moment for any European biotech company.…
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