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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02-12-2020

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
23-09-2020

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.
01-09-2020

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.
13-07-2020

The challenges to overcome age-related disease

In this article, Tom Hughes and Johan Strömquist discuss the challenges facing longevity research and the adoption of health span as a viable target for medicines in the future.
22-05-2020

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.
20-05-2020

Presentation of immunogenicity-related information in regulatory dossiers

How can an integrated summary report can be created to consolidate the information required for assessment of immunogenicity-related risks of different types of biopharmaceuticals.