New webinar
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…
View webinarFeatured resources
![Voisin Consulting Life Sciences default blog thumbnail](https://r5fb28.n3cdn1.secureserver.net/wp-content/themes/understrap-child/img/voisin_consulting_life_sciences_default_thumbnail_blog.png)
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…
![Voisin Consulting Life Sciences default blog thumbnail](https://r5fb28.n3cdn1.secureserver.net/wp-content/themes/understrap-child/img/voisin_consulting_life_sciences_default_thumbnail_blog.png)
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…
![Voisin Consulting Life Sciences default blog thumbnail](https://r5fb28.n3cdn1.secureserver.net/wp-content/themes/understrap-child/img/voisin_consulting_life_sciences_default_thumbnail_blog.png)
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…
![Voisin Consulting Life Sciences default webinar thumbnail](https://r5fb28.n3cdn1.secureserver.net/wp-content/themes/understrap-child/img/voisin_consulting_life_sciences_default_thumbnail_webinar.png)
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…
All our resources
More resources
![](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2024/06/Untitled-design-3-247x150.png)
Navigating the New FDA Draft Guidance on Platform Technologies: An Overview for Life Sciences Companies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…
![](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2024/06/Untitled-design-2-e1718596777822-247x150.png)
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…
![](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2024/06/3-247x150.png)
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…
![](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2024/05/Untitled-design-247x150.png)
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…
![](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2024/04/4-1-247x150.png)
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…
![](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2024/04/Achieve-Success-for-Your-First-US-Product-Application-Pathway-to-IND-247x150.png)
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.…
![](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2024/04/4-e1713347263212-247x150.png)
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…
![](https://r5fb28.n3cdn1.secureserver.net/wp-content/uploads/2022/04/EU-CTR-247x150.jpg)
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…