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Welcome to NDA - Europe’s leading regulatory affairs consultancy

NDA provides clients with a unique insight into EU regulatory thinking and the best possible expert guidance and support to optimise the time to the European market.

NDA’s mission is to ensure that patients get access to good medicines without unnecessary delay. NDA has successfully delivered on this promise for over ten years. Year on year, NDA have contributed towards more than 30% of new medicinal products receiving CHMP opinions, through strategic advice and operational support.

The experience and knowledge of NDA's regulatory consultants are unmatched in Europe.

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Aligning outcomes

In this commentary, that formed the basis for articles in MedNous as well as Scrip RA, NDA's Johan Strömquist discusses the situation facing industry, regulators and health technology assessors on their road to achieve the ultimate objective: Getting good medicines to patients.More of this story >

NDA's Paul Chamberlain speaking on Immunogenicity

NDA's Advisory Board member Paul Chamberlain is participating in three upcoming events. TOPRA MSc Regulatory Affairs, Module 9, 17 April, Cambridge UK, CHI Protein Engineering Summit 2012, Immunogenicity Track, 4 May, Boston USA and EUCRAF colloquium: “Immunogenicity Integrated” 4 June, Munich.More of this story >

Reduction in data requirements to be submitted to XEVPRM by July

As the date for the introduction of the new pharmacovigilance package is drawing nearer, the EMA is releasing more information on the new regulation. However, in January 2012, responding to industry concerns a decision was taken to considerably reduce the information to be submitted to Eudravigilance by the time of introduction of the new regulations. In this article NDA’s Barbara Jones describes the changes.More of this story >

NDA launches new Advisory Board and joint HTA/RA service

Following the succesful delivery of top level regulatory advice since 2002, NDA is now complementing its Regulatory Advisory Board with the addition of the NDA HTA Advisory Services. The new addition allows NDA to provide a unique advisory service, combining Europe's top level regulatory and HTA expertise to deliver joint advice.More of this story >

Graham Higson to lead NDA Advisory Board

GE Healthcare and ex AstraZeneca Head of Global Regulatory Affairs, Graham Higson, will join NDA Group in January 2012 to lead its unique-in-the industry Regulatory Affairs and HTA Advisory Board.More of this story >

The impact of the Paediatric Regulation on existing medicinal products

This article, written by NDAs Jill Challis, reviews the impact of the Regulation over the last five years on improving the likelihood for safer and more effective use of existing medicines in children.More of this story >

Making a success of new drug development

Wasting $60 billion on failed drug development programmes is unacceptable. But just how does the industry improve its strategy in getting new drugs to market quicker? NDA's CEO, Dr Lars-Helge Strömquist, comments on the state of the industry.More of this story >

Assessing whether your Rx product is ready for a switch to OTC in the EU

Pharmaceutical companies have many factors to consider in deciding whether a switch to over the counter is the right strategy for their products. NDA's Rosalind Cox recommends a structured approach.More of this story >

The NDA Group is an independent consulting organization delivering services within outcome oriented drug development focused on the strategic and operational aspects of regulatory affairs. NDA provides assistance to both the Pharmaceutical Industry as well as Regulatory Agencies. The ultimate objective of NDA is to help to develop better medicines that reach the patient without unnecessary delay. NDA achieves this objective by critically reviewing client project development plans with the aim that they are optimized to meet the needs of regulatory authorities and then to help to implement those strategies. NDA strives to bridge the communication gap between "the regulators" and "the regulated" to the benefit of patients.

The NDA Group provides services within several different areas such as regulatory affairs, pharmacovigilance and patient safety and quality assurance. NDA's regulatory consultants have extensive knowledge and experience working with traditional pharmaceuticals, biopharma, medical devices and production processes within the pharmaceutical industry.

The NDA Group also provides expert and strategic advice on development and regulatory strategies and assists the pharmaceutical industry with qualified training.