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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31-03-2021

NDA Webinars UK Regulatory Landscape post Brexit

In this webinar, Dr Thomas Lönngren and Patrick Mumo provide early initial insights into the changing UK regulatory landscape post brexit as the industry continues to adapt.
24-03-2021

Addressing the challenges of GTMPs

Dr Paula Salmikangas and Dr Björn Carlsson address the challenges related to the development of novel gene therapies.
18-03-2021

NDA Webinars Medical Device Regulation: Session 5

In the fifth session in our MDR seminar series, Dr Tina Amini walks you through the Post Market Surveillance (PMS) requirements under the EU MDR
09-03-2021

NDA Webinars Medical Device Regulation: Session 4

In the fourth session in our MDR seminar series, Dr Tina Amini walks you through the clinical evaluation of Medical Devices.
25-02-2021

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.
19-02-2021

NDA Webinars Medical Device Regulation: Session 3

In the third session in our MDR seminar series, Dr Tina Amini walks you through the details of the impact of EU MDR on Drug/Device Combination Products (DDCs).