NDA Group

  • NDA Group team
    We make sure that men, women and children all over the world get access
    to the best possible medicines without unnecessary delay.
  • Slideshow Image, family standing
    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.
  • Slideshow Image, family standing
    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.
  • Slideshow Image, family running
    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
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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.

In 2013 NDA supported more than 45% of the new marketing authorisations approved in the EU.

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Health Technology
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NDA Advisory
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Advisory Board Spotlight

Paul Chamberlain BSc (Hons)   |   Biopharmaceuticals Expert

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CHAMBERLAIN_PAUL How Paul can help your Business

Paul is a biopharmaceutical product development specialist, with particular interest in understanding and minimizing the risks associated with the undesirable immunogenicity of biopharmaceutical products. He specialises in presenting immunogenicity risk assessments for a diverse range of biopharmaceutical products, to EU and North American regulatory agencies.

Latest thought leadership contributions by Paul
  • Addressing immunogenicity-related risks in an integrated manner …
    Read more

Latest News from NDA

  • Brian_Edwards Dr Brian Edwards talks about Future Directions in Clinical Research
    Dr Brian Edwards is speaking at two events run by the Institute of Clinical Research’s Focus in April and May. The fi… Read more
    DG Dave Gilbert presents at Europe 101 - Opportunities for Collaboration & New Markets
    Dave Gilbert, member of the Advisory Board, has been invited to speak at MassBio forum Europe 101 - Opportunities for Co… Read more
    CHAMBERLAIN_PAUL Paul Chamberlain to present at FIP / PSWC
    Paul Chamberlain, a member of NDAs Regulatory Advisory Board, will be presenting at this years symposium at 5th FIP Phar… Read more
  • Morell_David Morell David presents at the EU MedDRA User Group Meeting 2014
    Morell David, Principal Consultant in Pharmacovigilance and Drug Safety at NDA Group, has been invited to present at thi… Read more
    NDA showcases new ATMP & risk management expertise at DIA EuroMeeting 2014
    At this year’s DIA EuroMeeting, 25-27 March 2014 in Vienna, NDA Group participates with a full contingent of senior expe… Read more
    Dr Panos Tsintis Panos Tsintis presents at DIA Risk Management Workshop in Japan
    Panos Tsintis, NDA Group Medical Advisor and Advisory Board member, will present at the DIA Risk Management Workshop in … Read more
We make sure that men, women and children all over the world get access
to the best possible medicines without unnecessary delay.