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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19-06-2019

Importance of Excellence in Scientific and regulatory Communication

In this white paper, Lisa Peluso discusses how excellent communications are the backbone of streamlined, efficient programs achieving approval and market access.
06-05-2019

4 ways that HTA will change under the new European regulation

In this white paper NDA's CEO, Johan Strömquist, discusses four ways that Health Technology Assessments will change under the new proposed European Regulation.
28-02-2019

Rare Diseases and FDA Advisory Committees: Be the Experts in the Room

NDAs Neelu Agrawal describes the unique challenges, along with key factors for success when preparing for an advisory committee for a rare disease.
20-01-2019

European Regulatory Meetings – how best to prepare and perform

In this article, NDA’s Steffen Thirstrup discusses three important factors to help you prepare for high stakes meetings with EU Regulators.
23-04-2018

The rationales and results of engaging early with regulators and HTA bodies.

Learn about the rationales and results of engaging early with regulators and HTA bodies.
13-06-2017

Partnership with Payers: Communicating and Negotiating with Impact

In this white paper you will learn about why excellence in communications is critical when it's time to defend the value and negotiate pricing. Prepare to win.