NDA Group

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    Working with NDA significantly changed the way we worked at Novartis. We needed strategic regulatory and development advice on how to overcome some of the hurdles we faced in the ever changing European regulatory environment. NDA helped us move away from the dark ages of regulatory affairs in order to achieve remarkable success.
    Novartis
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    NDA's expertise, knowledge, on top of
    their ability to deliver everything on time and to
    budget, all contributed towards our successful
    clinical trial programmes now underway in Europe.
    Athersys Inc.
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    A large part of our successful application and registration process can be attributed to the expertise, dedication and passion of the NDA Group team.
    US Pharmaceutical Company

Welcome to NDA Group

Europe’s leading regulatory drug development, pharmacovigilance and HTA consultancy

We support life science companies all over the world and across all phases of development, from pre-clinical to post marketing, to the needs and requirements of regulators and payers alike. We work together with our clients to address key strategic regulatory and reimbursement challenges. Our scientific expertise covers all major therapeutic areas.

The advice you get from NDA is from real experts in the industry, many who have been involved in shaping today’s regulatory, HTA and pharmacovigilance environment. We have close to 100 employees across Europe. More than 25% are ex EU regulators.

With our support, you can cut the time and associated cost it takes to get your products to market, and keep them there.

NDA supported more than 45% of the new medicinal products that were approved in the EU in 2013.


Regulatory
Affairs
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Pharmacovigilance
and Quality
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Health Technology
Assessment
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NDA Advisory
Boards
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Advisory Board Spotlight

Dr Simon Day PhD   |   Statistical Expert

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Simon_Day2 How Simon can help your Business

Simon is the former head of the Statistics Unit at MHRA. He has over 30 years statistics and clinical trials expertise, has worked as a senior consulting statistician within Roche, and was vice-chairman for CHMP Scientific Advice Working Party. Simon has held many scientific journal editorial posts, he is a former President of the International Society for Clinical Biostatistics. In 2012, Simon was elected a Fellow of the Society for Clinical Trials. Simon can assist you with any strategy and detail for constructing clinical development plans as well as answering questions from health authorities.


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Latest News from NDA

  • Thomas_Lönngren NDAs Thomas Lönngren speaks at ARCS Australia 12 December, Sydney
    Dr Lönngren will share his experiences gained from working at the European Medicines Agency at a course held at ARCS in … Read more
    Brian_Edwards Dr. Edwards presenting at this year’s meeting of the British Pharmacology Society
    NDAs Dr. Edwards is giving an oral presentation and a poster presentation at this year’s meeting of the British Pharmaco… Read more
    dia germany Biosimilars Conference 2014
    NDA Group will have a strong presence from its Advisory Board at this years’ Biosimilars Conference 2014. NDA Advisory B… Read more
  • B_Jonsson Bengt Jönsson awarded ISPOR Lifetime Achievement Award
    Bengt Jönsson, Chairman of the NDA HTA Advisory Board, has been awarded the prestigious ISPOR Avedis Donabedian Outcomes… Read more
    World-Biosimilar-Congress-2 World Biosimilar Congress, Geneva, 11-12 November
    NDA Advisory Board Members, Paul Chamberlain and Steffen Thirstrup, will be presenting at this year’s World Biosimilar C… Read more
    diaj Meet NDA at DIA Japan11th Annual Meeting in Tokyo
    NDA Group will be exhibiting at this year’s DIA Japan 2014 11th Annual Meeting, taking place in Tokyo from November 16-1… Read more
We make sure that men, women and children all over the world get access
to the best possible medicines without unnecessary delay.