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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Addressing the challenges of GTMPs

Dr Paula Salmikangas and Dr Björn Carlsson address the challenges related to the development of novel gene therapies.

Starting out with the end in mind

Since 2009, Paul Chamberlain has pioneered the submission of a multidisciplinary section of the CTD format to provide regulatory assessors with an extended data analysis.

Expedited regulatory pathways: EU and US approaches

What you have and what you want decides which tool to use – insights into the expedited regulatory pathways in the EU and US

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.

Potential Consequences of SARS-CoV-2 to ongoing clinical programs

In this white paper, NDA’s Dr Laurie Smaldone discusses the potential impact of COVID-19 on on-going clinical trials.