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

  • Brian_Edwards Dr. Edwards presents at ISoP-Italian Society of Pharmacology symposium
    NDA’s Dr. Brian Edwards is speaking at the ISoP-Italian Society of Pharmacology joint symposium in Bologna on the 7th Ma… Read more
    Thomas_Lönngren Dr. Lönngren speaks at the 5th Annual R&D Leadership Summit
    NDA’s strategic advisor, Dr. Thomas Lönngren, has been invited to chair and present at the 5th Annual R&D Leadership… Read more
    timthumb Brian Edwards speaks at the 8th Pharmacovigilance 2015
    NDAs Brian Edwards is speaking at the 8th Pharmacovigilance 2015, 24th-25th Feb, at Marriott Marble Arch Hotel, London U… Read more
  • Medicines for women NDAs Brian Edwards co-authors chapter in “Medicines for Women”
    In this definitive new text, the major medicines, devices and vaccines used by women worldwide are brought together for … Read more
    NDA expands HTA Advisory Board
    NDA Group is expanding its expertise in HTA and health economics by bringing on board six new experts to its HTA Advisor… Read more
    Shelley_Gandhi Shelley Gandhi speaks at PV and Risk Management Conference
    Shelley Gandhi, one of NDA’s leading experts in Pharmacovigilance, is presenting at the 5th Annual conference on Pharmac… Read more
We make sure that men, women and children all over the world get access
to the best possible medicines without unnecessary delay.