Thought Leadership

At NDA our experts stay abreast with the evolving environment and the new regulatory requirements that it gives rise to. One of the results of these activities is a stream of articles, commentaries and white papers that we publish for the benefit of our clients and followers. It captures the state of the art of our industry today.

We call it Thought Leadership.

Articles and White Papers



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Oral explanation – Your product’s last stand

In this article, we provide insight into oral explanations and what you need to emphasize in a presentation in order to engage with EU regulators.

Controlled Human Infection Studies

NDA's Dr Paula Salmikangas and Dr Pieter Neels co-wrote and shared their knowledge in this insightful article that was published on the 4th of October in Biologicals. 

A new dawn in Regulation and Access

Scientific Writer, Ingela Loell, provides insight into ILAP and the collaborations providing quicker approval and patient access.

NDA Webinar: Optimise your interactions with European Regulatory Agencies

In this webinar Dr Roz Cox discusses the opportunities for interacting with European Regulatory Agencies, and how to optimise these interactions

Vaccine platform technologies – Learnings from the COVID-19 pandemic

NDA Advisory Board Members, Steffen Thirstrup and Pieter Neels provide an insight into current vaccine platform technology and how the rapid response to tackle emerging infectious diseases can be further improved.

Patient Access in the real world: Addressing challenges and opportunities.

NDA Advisory Board Members, Mel Walker and Yngve Mikkelsen provide an insight into how global events can impact patient access in a real-world setting.