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 38% of the new medicinal products that were approved in the EU in 2014.


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

Dr Simon Day PhD   |   Statistical Expert

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Dr Simon Day 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

  • 3688cde NDA Group sponsors CMO East and West Summits in USA
    NDA Group has signed an agreement to become an Executive Sponsor of the CMO East and West Summits in the USA. Both confe… Read more
    Gopalan Narayanan Making Progress with Biosimilars
    NDA Group’s Dr Gopalan Narayanan has written an article addressing the market for biosimilars as a lower-cost alternativ… Read more
    NDA leads on integrated Regulatory & HTA strategy at DIA EU 2015
    Seven NDA experts present on Pharmacovigilance, Risk Management Planning, ATMPs, EU Clinical Trial Regulations and Discl… Read more
  • Dr. Thomas Lönngren's article in 20 year anniversary EMA book
    NDA's Strategic Advisor and former head of the EMA, Dr. Thomas Lönngren, has had the honour of being asked to provide … Read more
    Dr Thomas Lönngren Dr. Lönngren speaks at CoRE Symposium in Singapore
    NDA’s Dr. Thomas Lönngren has been invited by Duke-NUS Graduate Medical School to speak at the CoRE (Centre of Regulator… Read more
    NDA at the DIA EuroMeeting / Annual Clinical Forum 2015
    NDA Group will be attending this year’s DIA EuroMeeting / Annual Clinical Forum on 13-15 April in Paris. We will have a … Read more
We make sure that men, women and children all over the world get access
to the best possible medicines without unnecessary delay.