NDA Group

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

  • 3167_4974 - Copy Dr. Edwards speaks at Energy Challenges and Mechanics symposium
    Dr. Edwards, Pharmacovigilance veteran and expert at NDA Group, is speaking and moderating at the 3rd International Symp… Read more
    Johan Achieving safe and timely access to medicines
    This commentary by NDA CEO Johan Strömquist is focusing on what Europe is doing – from a regulatory perspective – to pro… Read more
    Dr Steffen Thirstrup NDA’s Prof. Thirstrup presents on Adaptive Pathways
    NDA Group’s Professor Steffen Thirstrup is presenting at the Adaptive Pathways Workshop, run by DIA and TOPRA, on 30th J… Read more
  • NDA at the Pharmacovigilance forum in London
    NDA's Shelley Gandhi, Pharmacovigilance & Drug safety Expert, will chair and Dr. Bill Richardson, Medical Advisor at… Read more
    Gopalan Narayanan New Podcast on Global Regulation of Advanced Therapies
    NDA’s Biologics and Advanced Therapy Expert Dr Gopalan Narayanan, has a new podcast available to view on: Global Regulat… Read more
    NDA Group and PharmApprove Announce Strategic Alliance
    New Collaboration Offers Seamless Global Regulatory, Scientific, and Market Access Communications Services to Life Scien… Read more
We make sure that men, women and children all over the world get access
to the best possible medicines without unnecessary delay.