NDA Group is a world leading regulatory and drug development consultancy with a dedicated team of over 150 consultants supported by an expert network and a specialist Advisory Board. Our goal is to streamline drug development in order to accelerate patient access to important medical therapies.

About NDA

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vigilance

High-Stakes Meetings

Medical Devices

News

How to Keep up With The Fast-Evolving World of ATMPs

28th October 2020

Join us on Thursday 19th November 2020, 15:00 GMT | 16:00 CET | 10:00 EST, when Dr Paula Salmikangas and Professor Steffen Thirstrup discuss how to keep up with the Fast-Evolving World of ATMPs.

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Expedited Reviews: What you need to know to be Successful

19th October 2020

This case study is an excellent example of how a well-planned and meticulously executed regulatory strategy can lead to a collaborative and rapid review

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Optimizing Global Submissions in the Age of Rapidly Advancing Innovation and Rare Disease

14th October 2020

Do not miss the panel discussion moderated by Laurie Smaldone, CMO/CSO at NDA, about the major challenges in global drug development for rare diseases.

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Remote audits – The new normal

7th October 2020

In this whitepaper, we will provide tips and good practices for remote audits as an alternative method to conducting traditional on-site audit.

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Integrated product development for ATMPs

23rd September 2020

Claes Buxfeldt and Paula Salmikangas discuss why an integrated product development strategy for ATMPs is essential to meet both regulatory and HTA requirements.

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Leveraging Expedited Regulatory Pathways to Optimize Drug Development

8th September 2020

Join us on Thursday 24th September 2020, 15:00 BST | 16:00 CEST | 10:00 EDT, when Dr Frank Casty, Judith Plon and Professor Steffen Thirstrup will guide you through the expedited regulatory pathways available in the EU and US.

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Expedited Reviews: What you need to know to be successful

5th September 2020

Throughout the drug development process there are many factors influencing speed to market but none more visible and critical than an expedited regulatory review.

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We have helped over 2,000 clients achieve success in the past
We have helped over 2,000 clients achieve success in the past

The leader in FDA Advisory Committee meeting preparation

“For innovative life science companies, NDA and PharmApprove are the best partners to help prepare to win at FDA Advisory Committees. Our pioneering approach — refined over 16 years experience and 150-plus projects — has helped more than 80 clients achieve success at these high-profile, high-stakes hearings.

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A Career with NDA

Join NDA and get the chance to work with some of the leading minds in regulatory affairs, pharmacovigilance, health technology assessment and scientific communications on a variety of projects, clients and geographies.

Why work at NDA?

Our Locations

NDA Sweden

NDA Group AB
Johanneslundsv. 2
S-194 61 Upplands Väsby
Sweden

T. +46 (0)8 590 778 00
E. stockholm@ndareg.com

NDA France

7, rue Jobbé Duval,
75015 Paris,
France

T. +33 983 981 942
E. paris@ndareg.com

NDA Germany

Neumarkter Straße 18
D-81673 München
Germany

T. +49 (0)89 3585 4000
E. munich@ndareg.com

NDA Switzerland

Rigistrasse 5
8703 Erlenbach
Switzerland

T. +41 (0)78 951 9929
E. zurich@ndareg.com

NDA UK

Grove House
Guildford Road
Leatherhead,
Surrey KT22 9DF
United Kingdom

T. +44 (0) 1372 860 610
E. london@ndareg.com

NDA USA Massachusetts

NDA Regulatory Development Inc.
1 Broadway, 14th floor
Cambridge, MA 02142
United States

T. +1 609 583 1990
E. usa@ndareg.com

NDA USA New Jersey

PharmApprove
200 Princeton South Corporate Center,
Suite 340
Ewing, NJ 08628
United States

T. +1 609 583 1990
E. usa@ndareg.com