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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Regulatory Affairs

Pharmaco-
vigilance

High-Stakes Meetings

Medical Devices

News

Are you attending the Virtual DIA Europe 2020 Conference?

24th June 2020

Our team would love to connect with you during the DIA Europe and discuss how we can support you to optimise your path to market approval.

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Preparing for the Medical Device Regulation

8th June 2020

Join Stephanie Krumholz and Tina Amini for our first interactive virtual webinar on the 3rd of July at 10am CET.

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Interview with Kurt Stoeckli, President NDA Advisory Services

5th June 2020

From climbing mountains to President of NDA’s Advisory Board, in this interview we learn where Kurt’s passion for science began, the biggest challenges in his career and his vision for the NDA Advisory Board.

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Enhancing Pharmacovigilance

2nd June 2020

In this article, Dr Brian Edwards follows on from his very successful webinar, Opportunities to enhance Pharmacovigilance in Oncology, to argue that to maximise the benefits of innovation in our products we need innovative pharmacovigilance.

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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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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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Members

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