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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. This webinar will cover the…
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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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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…
Best ePRO practices – A patient centric approach
The adoption of Electronic Patient-Reported Outcomes (ePRO) in clinical research marks a significant evolution in the way patient-centered data is…
Q&A regarding common concerns of China’s NMPA (National Medical Products Administration)
The rapid development of China’s pharmaceutical market has attracted the attention of many international health–tech companies. China has a huge…
Getting an Early Access Program Off the Ground Safely
Embracing an Early Access Program (EAP) presents a strategic avenue for creating valuable opportunities for patients and companies. This webinar…