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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Project Orbis: What a pharmaceutical company needs to know

In this article, NDA's Senior Consultant and Project Orbis lead Claudia Reichle provides background and practical information on the FDA driven initiative Project Orbis.

NDA Webinars Project Orbis: What you need to know

In this webinar our Senior Consultant and Project Orbis Lead, Claudia Reichle provides a closer look at Project Orbis and discusses what you should think about if you are offered the possibility to take part.

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.

Enhancing Pharmacovigilance

This article discusses the tremendous expansion in oncology products with great opportunities that will benefit patients.

New EU In vitro Diagnostics Regulation (IVDR) and Companion Diagnostics

The companion diagnostics market is an emerging market and is anticipated to experience significant growth owing to increase in targeted therapies, rise in demand for personalised medicine with increase in awareness in emerging economies, discovery of n...