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Navigating the New FDA Draft Guidance on Platform Technologies: An Overview for Life Sciences Companies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…
blog
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…
blog
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.…
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…
blog
Navigating the FDA Draft Guidance Document “Manufacturing Changes and Comparability for Human Cellular and Gene…
In the ever-evolving landscape of pharmaceuticals/biopharmaceuticals, manufacturing changes play a pivotal role in ensuring the quality and effectiveness of medicinal…
blog
FDA Meeting Series: How, When and What – INTERACT Meetings
INTERACT Meetings What: CDER is now also accepting INTERACT Meetings. Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products (INTERACT)…
Case study
Innovative Marketing Authorization Transfer Preserves Vital Patient Supply
The marketing authorization is a key step in the product development pipeline of any healthtech product. It involves the assessment…
blog
FDA Meeting Series: How, When and What – EOP Meetings
End-of-phase (EOP) meetings occur when development has reached the end of a particular phase and is ready to move to…
