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



Sort by:


Going Faster – How Project Orbis and ACCESS Consortium Expedite Cross-Jurisdictional Approvals

In this white paper, Ricarda Meinecke provides guidance if you are considering parallel submissions in several jurisdictions for your product.

Payer Negotiations – Identifying and overcoming the challenges

In this whitepaper, Steffen Thirstrup and Carole Longson highlight the different viewpoints between the regulatory and HTA assessment to guide you on how best to prepare for a positive outcome in both assessments.

The outlook for gene editing in treating disease

Dr Paula Salmikangas, Dr Björn Carlsson and Dr Steffen Thirstrup address the risks and challenges of gene editing.

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.