A French biotech had developed a live biotherapeutic product to target obesity and metabolic disease but were hindered by blocking points in the product development process. We worked alongside the Client to identify the specific regulatory and scientific gaps in their plan. This critical information helped to form the solid foundation of their regulatory strategy and nonclinical development plan.
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Phages, also known as Bacteriophages, are viruses that infect specific bacteria and provoke their death via lytic activity. They are…
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Over the past decade, innovations in both sequencing technology and computational biology have led to a growing interest in profiling…
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The current European regulatory framework for Blood Tissue and Cells is being replaced by a new Regulation, which includes a…
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As professionals in the life sciences industry, we work in a regulated environment and we are a key element in…
