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.
Latest Blog posts
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Navigating the New FDA Draft Guidance on Platform Technologies: An Overview for Life Sciences Companies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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A deep dive into the regulatory framework for Phage Medicinal Products
Phages, also known as Bacteriophages, are viruses that infect specific bacteria and provoke their death via lytic activity. They are…
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Sponsors of Clinical Trials in the EU/EEA – Call for Action!
2024 is here and will be a crucial year for your clinical trials in the European Union (EU) and European…
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Digital Health Series – Part 5: Key Challenges for Software and AI as a Medical…
In our previous posts, we explored software tools used in digital health and set the foundations around potential applications of…
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