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.

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vigilance

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News

Potential Consequences of SARS-CoV-2 to ongoing clinical programs

22nd May 2020

In this white paper, NDA’s Laurie Smaldone discusses the potential impact of COVID-19 on on-going clinical trials.

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What did we learn from the 2009 pandemic?

15th May 2020

In this commentary, NDA’s Thomas Lönngren discusses the regulatory learnings from the 2009 pandemic and how these are applicable to the current pandemic.

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Medical Device Regulation: Key Changes and what it means for Combination Products

13th May 2020

On Thursday 4th June 2020, 15:00 BST | 16:00 CEST | 10:00 EDT, Dr Tina Amini, Medical Device Division Director, NDA Group will guide you through the key points to consider in your efforts to become Medical device regulation (MDR) compliant and focus on the implementation of MDR Article 117.

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Medical Devices and their growing regulatory challenges

14th April 2020

In this article, NDA’s Tina Amini explains what companies need to look out for in the growing area of device regulation.

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Kurt Stoeckli joins NDA as President NDA Advisory Services

2nd April 2020

We are happy to announce and welcome Kurt Stoeckli to the team as President NDA Advisory Board.

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Webinar – Opportunities to Enhance Pharmacovigilance in Oncology

31st March 2020

On Thursday 23 April 2020, 15:00 BST, 16:00 CEST & 10:00 EDT,  Dr Brian Edwards Principal Consultant, Pharmacovigilance & Drug Safety, NDA Group, will discuss current best practices and opportunities for future improvement in oncology safety processes.

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NDA Medical Device Division launched

19th March 2020

We are proud to announce the creation of a new division within NDA, focusing on advice and support to companies facing increasing regulatory challenges in the device space.

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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.

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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