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
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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.

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

Dr Julia Dunne MA(Oxon), FRCP, Hon.FRCPCH   |   Medical Advisor

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Julia_Dunne How Julia can help your Business

Julia is an expert in paediatric drug development, pharmacovigilance and risk management, as well as having broad and longstanding regulatory experience. She has held regulatory and scientific positions in the MHRA (most recently, Group Manager, Special Populations Unit), the FDA (scientific adviser, Office of Pediatric Therapeutics), and the European Commission (secondment to the Pharmaceuticals Unit, DG Enterprise). She is a former member of the PDCO, PRAC, CHMP and the Committee for Orphan Medicinal Products (EMA).


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Latest News from NDA

  • Massbio Biotech and NCE Client Seminar in Boston
    How confident are you of getting your biologic and new chemical entity drug into the EU market? Free seminar for biotech… Read more
    Markku_Toivonen Clinical development of cancer medicinal products
    NDA's Markku Toivonen will present on ‘Clinical development of medicinal products for the treatment of cancer – regulato… Read more
    book NDA authors Mann’s Pharmacovigilance
    NDAs Brian Edwards and Shelley Gandhi have written chapter 2 Legal Basis – European Union under the headline The Regulat… Read more
  • Brian_Edwards Brian Edwards presents at ISoP 2014 Asia
    One of NDAs pharmacovigilance experts, Dr. Brian Edwards, is presenting at this years 14th Annual Meeting of Internation… Read more
    Professor Bengt Jönsson NDA’s Bengt Jönsson co-authors HTA Effectiveness Article
    The article provides an overview of how to address crossover, implications for risk-effect estimates of survival (hazard… Read more
    Invitation Biotech and NCE Client Seminar in Boston
    How confident are you of getting your biologic and new chemical entity drug into the EU market? Free seminar for biotech… Read more
We make sure that men, women and children all over the world get access
to the best possible medicines without unnecessary delay.