NDA Group

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 over 45% of the new medicinal products that were approved in the EU during 2013-2015.


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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Expert Spotlight

Dr Mira Pavlovic-Ganascia MD   |   Advisory Board Member

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Mira Pavlovic-Ganascia_small How Mira can help your Business

Mira is a practicing dermatologist and former Deputy Director for Health Technology Assessment at the Hauté Autorité de Santé (HAS) in France with extensive experience from EUnetHTA and previously the EMA and the French AFSSAPS. Mira brings extensive and hands-on HTA experience, with deep insights from the EUnetHTA initiative and what clients need to consider when approaching joint regulatory and HTA advice in the EU.

Latest thought leadership contributions by Mira
  • Managing uncertainties – early dialogue for early market access in Europe…
    Read more

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Latest News from NDA

  • Untitled-1 Senior Regulatory Affairs Consultant with Global Focus
    Are you an experienced specialist in regulatory affairs within drug development on a global level? Become a part of NDA’… Read more
    Global Head of HR for leading life science consultancy
    Are you the right person to launch new, strategically important, global HR initiatives in a growing company with a famil… Read more
    Thomas Lonngren Low Res (2) Dr. Lönngren co-authors articles on multi criteria decision analysis
    Dr. Thomas Lönngren, NDA Strategic Advisor, has co-authored two articles for ISPOR MCDA Emerging Good Practices Task For… Read more
  • Paul_Chamberlain NDAs Paul Chamberlain writes about the Diversity of Biosimilar Development
    NDA Advisory Board member, Paul Chamberlain, has co-authored an article titled “Controversies in Establishing Biosimilar… Read more
    Shelley_Gandhi Shelley Gandhi presents on Signal Detection
    Shelley Gandhi, Strategic Advisor Pharmacovigilance & Drug Safety NDA Group, will be presenting on Signal Detection … Read more
    Steffen Professor Thirstrup speaks about “New therapeutic areas and their challenges”
    Steffen Thirstrup, Director of NDA’s Regulatory Advisory Board, has been invited by the Danish Association of the Pharma… Read more
We make sure that men, women and children all over the world get access
to the best possible medicines without unnecessary delay.