NDA Group

Welcome to NDA Group

The world’s leading drug development consultancy

We support life science companies all over the world with the single aim to streamline the global development and commercialization process in order to accelerate patient access to important medical therapies.

NDA comprises over 150 dedicated consultants with industry and regulatory agency backgrounds, supported by a network of over 1 000 scientific, clinical, regulatory and drug development experts. Our advice covers all phases of development and all major therapeutic areas.

On March 1st 2016 NDA merged with PharmApprove – the scientific communications firm in the US, world leaders in preparing and managing successful FDA Advisory Committee Meetings.

NDA supported over 45% of the new medicinal products that were approved in the EU during 2013-2015. In addition PharmApprove’s success rate for FDA Advisory Committee Meetings tops 85% in the same time period.

With our support you can cut the time and cost it takes to get your product to the patients that need them.


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

  • ChiefMedicalOfficerSummitLogoShort Dr. Thomas Lönngren presents at CMO East
    Dr Thomas Lönngren gives an European regulatory update at the Chief Medical Officer Summit East in Boston 12th May.… Read more
    Thomas-Lonngren-Low-Res-2-450x637 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
    Frits Lekkerkerker Evolving Landscape on Data Requirements to Demonstrate Biosimilarity
    Hear Dr. Frits Lekkerkerker, NDA Advisory Board member, present on 'Evolving Landscape on Data Requirements to Demonstra… Read more
  • Steffen-Thirstrup_small Adaptive Pathways: challenges & opportunities for Regulatory, HTA & Payers
    NDA invites to free breakfast seminar where Professor Steffen Thirstrup will inform on the latest developments in EU Ada… Read more
    bannerbig Meet NDA Group at PEGS in Boston
    If you are planning to attend this year’s PEGS, we would really like to meet up with you. You will find us at Booth 341,… Read more
    NDA-Infographic-2016-8 Europe Vs USA: new drug product approvals in 2015
    What are the key differences in new drug product approvals across the US and EU regions? Learn about the state of drug 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.