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How to master both Marketing Authorization and Joint Clinical Assessment successfully?
The European Union is transforming its health technology assessment process with the introduction of the Joint Clinical Assessment (JCA) under the new HTA Regulation. This major change aims to streamline…
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Selection of a Notified Body for Medical Device Development
In the European Union (EU) the review and approval of medical devices and in vitro diagnostic medical devices often requires…
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Digital Health Series – Part 1: Defining Software as a Medical Device
Recently, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has provided updates to the guidance Software and AI…
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Importance of Quality Management Review for Medical Devices
If you are an innovator developing a device, it is critical to understand the purpose and innerworkings of quality management…
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Ask the Experts: MHRA’s Innovative Licensing and Access Pathway (ILAP)
In its new role of an independent regulator, the UK’s MHRA regulatory agency is emerging as a flexible and welcoming…
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webinar
How to master both Marketing Authorization and Joint Clinical Assessment successfully?
The European Union is transforming its health technology assessment process with the introduction of the Joint Clinical Assessment (JCA) under…
blog
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…
blog
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…
webinar
Ask the Experts: How to leverage regulatory interactions to de-risk Microbiome products development in the…
Microbiome science has grown over the past years with high potential to provide innovative, efficient, and targeted solutions to various…
blog
Navigating the New FDA Draft Guidance on Platform Technologies: An Overview for Life Sciences Companies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…
Case study
Building an Efficient Path Towards Phase 2 Clinical Study in the US for a Live…
An APAC-based biotech had developed a live biotherapeutic product to target a rare liver disease with a high unmet medical…
