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.
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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.

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Health Technology
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NDA Advisory
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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

  • DrTL Dr. Lönngren participates in a reactor panel on patient access to orphan drugs
    NDA's Thomas Lönngren will participate in a reactor panel on patient access to orphan drugs in the US and Europe at the … Read more
    NLSDays2014 Meet NDA at Nordic Life Science Days 7-9 September
    Nordic Life Science Days is the largest Nordic partnering conference for the global Life Science industry. Bringing toge… Read more
    Olga_Bjorklund State of US and Europe new drug product approvals in 2013
    Over the past couple of months we’ve researched data on the state of new drug product approvals in the EU and the US. Ou… Read more
  • NDA_Info-10A-CS3 Aug 2014 Resize Drug Approvals Infographic
    Today we have launched a new Infographic that highlights the state of drug approvals in 2013 in Europe and the USA. … Read more
    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
We make sure that men, women and children all over the world get access
to the best possible medicines without unnecessary delay.