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 38% of the new medicinal products that were approved in the EU in 2014.


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

Gopalan Narayanan   |   Biologics and Advanced Therapy Expert

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Gopalan Narayanan How Narayanan can help your Business

Dr. Narayanan has substantial experience in the area of biologics, advanced therapies and biosimilars. He has dual specialist postgraduate qualification in general internal medicine and pharmaceutical medicine. He was Manager of the Biotechnology unit at MHRA and Expert Medical Assessor and he is on the scientific editorial board of Gene Therapy Clinical Development journal. Narayanan can assist you with any support clients require in regulatory science aspects of life-cycle management in the field of Advanced Therapies and other complex biologics, with particular expertise in clinical development.


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Latest News from NDA

  • Dr Markku Toivonen NDA Advisory Board member Markku Toivonen speaks at EURORDIS summer school
    Dr. Toivonen will present on two topics at the Expert Patients and Researchers EURORDIS Summer School in Barcelona June … Read more
    Untitled-2 Meet NDA at DIA USA and BIO conventions
    This June, NDA will be attending the DIA USA and BIO convention. NDA’s experts will present on a number of critical drug… Read more
    Dr. Thomas Lönngren Dr Lönngren Presents at ISPOR Philadelphia
    Dr Thomas Lönngren will be presenting at the  ISPOR 20th Annual International Meeting held in Philadelphia, 16-20th May … Read more
  • NDA-Infographic New article: Europe Vs USA: new drug product approvals in 2014
    In recent weeks, we have gathered together the data made publicly available on the state of new drug product approvals i… Read more
    NDA-Infographic Drug Approvals Infographic EU vs USA 2014
    Nearly 40% of new products approved from non top pharma in 2014. Findings of new Infographic highlights state of drug ap… Read more
    3688cde NDA Group sponsors CMO East and West Summits in USA
    NDA Group has signed an agreement to become an Executive Sponsor of the CMO East and West Summits in the USA. Both confe… Read more
We make sure that men, women and children all over the world get access
to the best possible medicines without unnecessary delay.