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

  • NA_16001_308x308 Meet NDA at DIA USA
    Don't miss the opportunity to meet our Experts who will present on a number of critical drug development related topics … Read more
    Global Pharmacovigilance Regulatory Requirements: What’s New?
    NDAs Shelley Gandhi and Bridget King talks about Global Pharmacovigilance Regulatory Requirements at the Drug Safety Res… Read more
    Thomas-Lonngren-Low-Res-2-450x637 Thomas Lönngren presents at the Boston CEO Conference
    Dr. Thomas Lönngren, Strategic Advisor NDA Group, has been invited to speak in the session 'How Will We Pay for Cures?' … Read more
  • Dr Brian Edwards Pharmacovigilance's role in rapid access to safer drugs
    NDA's Dr. Edwards has been invited to talk at the Uppsala Forum Research Conference "Pharmacovigilance's role in rapid a… Read more
    3167_4974 - Copy Dr. Edwards talks about FDA’s views on Clinical Safety
    Dr. Brian Edwards has been invited to talk about FDA’s views on Clinical Safety at the China Academy of Chinese Medical … Read more
    Brian_Edwards Dr Edwards gives an update on Risk Communication at DIA China
    NDAs Dr Brian Edwards gives an update on Risk Communication at the DIA China 8th Annual Meeting at the China National Co… Read more
We make sure that men, women and children all over the world get access
to the best possible medicines without unnecessary delay.