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.

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.

Integrated product development for ATMPs

In this article, published in the September issue of MedNous, Claes and Paula discuss why an integrated product development strategy for ATMPs is essential to meet both regulatory and HTA requirements.

Market access for immune-oncology products in the EU

In this article, published in Volume 22 September 2020 of Pharmafocus, Claes Buxfeldt discusses key considerations in early development to succeed with market access for immune-oncology products in the EU.