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Pediatric Development – Regulatory Aspects in EU and US

25th June 2019

Welcome to NDA’s seminar on 16 July 09:00-11:00 in Munich, Germany, on Pediatric Development – Regulatory Aspects in EU and US.

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European Regulatory Meetings – how best to prepare and perform

20th June 2019

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

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Importance of Excellence in Scientific and regulatory Communication

19th June 2019

In this white paper, PharmApprove’s Lisa Peluso discusses how  excellent communications are  the backbone of streamlined, efficient programs achieving approval and market access.

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Meet the NDA Group at DIA in San Diego 23-27 June

14th June 2019

We will be attending DIA in San Diege 23-27 June. If you are planning to be there, we would really like to meet up with you!

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Navigating the Regulatory Maze – Initiating Your Phase 1 Trials

4th June 2019

Welcome to NDA’s seminar on 2 July 12:00-14:00 in Cambridge, UK, on Navigating the Regulatory Maze – Initiating Your Phase 1 Trials.

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Solve your most difficult regulatory challenge at BIO Philadelphia

27th May 2019

The path to approval is littered with pitfalls leading to unnecessary delays getting your medicine to the people who need it the most….the patients. Meet Dr Laurie Smaldone Alsup for a talk about how to resolve the issues.

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Why should you engage early with regulators and HTA bodies?

14th May 2019

NDA’s Dr Mira Pavlovic-Ganascia and Claes Buxfeldt provide insight on what the expected outcomes of constructively engaging with regulators and HTA bodies could be.

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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

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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