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Demystifying the US IND process for initiation of clinical trials
Submitting an Investigational New Drug (IND) application to the US FDA is a significant step in the development of a new drug or biologic product. In this webinar, we covered…
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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…
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…
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…
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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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.…
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…
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…
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…
Digital Health Series – Part 4: Software as a Medical Device Regulated by the UK
Previously, we talked about how the EU regulates Software as Medical Device (SaMD), including AI-based software. Given that UK is…
Demystifying the US IND process for initiation of clinical trials
Submitting an Investigational New Drug (IND) application to the US FDA is a significant step in the development of a…
The International Recognition Procedure – The United Kingdom’s new route for accelerated marketing authorization
Following the UK’s departure from the EU In 2021, the MHRA has introduced several initiatives to foster product development and…
Creating a complex IND whilst safeguarding confidential data between a CGT spin-off and CDMO
When submitting and IND for CGT product/therapy, it’s crucial to confirm that the viral vector in use is appropriate, especially…