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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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.

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.

Effective presentation of immunogenicity related data in regulatory dossiers

NDAs Paul Chamberlain provides practical advice about how to present immunogenicity-related information in regulatory dossiers in the latest publication of Bioanalysis.

CAR T-Cells for Cancer Immunotherapy – Moving Target for Industry?

This article discusses the product-and patient-related variables that may pose challenges for the industry and developers both from the scientific and regulatory perspective.