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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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.
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.
17-05-2018
Regulatory strategies for value maximisation of early clinical stage assets
This white paper written by Niamh Kinsella, Biologics Expert, Paul Chamberlain, Biopharmaceuticals Expert, Josi Holz, Clinical Strategy Expert and Eva Lilienberg, Service area lead Global Development, focus on how you can strengthen your partnering nego...
19-02-2016
Adapting to new clinical trial regulation in EU
With the EU Clinical Trial Regulation coming into effect, by October 2018 at the latest, sponsors should start, preparing for the new legislative framework to maximise, positive efficiencies and minimise any burdens