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 45% of the new medicinal products that were approved in the EU in 2013.


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

Professor Beatriz Silva Lima PharmD, PhD   |   Non-Clinical Expert

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Beatriz_Silva_-Lima2 How Beatriz can help your Business

Beatriz is an expert in non-clinical and regulatory science, stemming from many years working for the Portuguese agency - Infarmed - and at the EMA. She is a former member of the CHMP, CAT and SAWP, Chair of the SWP, as well as and has being involved in ICH discussions on several non-clinical guidelines on behalf of the European Commission. Beatriz can assist with any non-clinical strategic advice and support, from small molecules to advanced therapies.


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Latest News from NDA

  • farmakologi_FORSIDE Steffen Thirstrup’s Pharmacology textbook
    NDA’s Regulatory Advisory Board Director, Steffen Thirstrup, has had the pleasure of being one of four editors of th… Read more
    DrTL Thomas Lönngren in Pharma Times
    NDA Group’s Strategic Advisor, Thomas Lönngren, has had a letter to the editor published in this month’s Pharma Time… Read more
    Johan Stromquist Adaptive licensing and exploratory pathways
    This article by NDA CEO Johan Strömquist, deals with new and emerging regulatory pathways such as breakthrough designati… Read more
  • CHAMBERLAIN_PAUL Paul Chamberlain co-authors article on Interchangeability of biosimilars
    NDA Advisory Board member, Paul Chamberlain, has just had an article, written in collaboration with Dr Hans Ebbers (Univ… Read more
    Gopalan_Narayanan Making Progress with Biosimilars
    NDA Group’s Dr Gopalan Narayanan has published an article in EBR magazine addressing the market for biosimilars as a low… Read more
    CHAMBERLAIN_PAUL Paul Chamberlain review article on immunogenicity of biosimilars
    NDA Advisory Board member, Paul Chamberlain, has just had an article published in Biosimilars magazine. The article is t… Read more
We make sure that men, women and children all over the world get access
to the best possible medicines without unnecessary delay.