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NDA - Regulatory Affairs and Development Consultancy Partner

NDA is the pharmaceutical industry's leading European regulatory affairs and development consultancy partner, as confirmed by the unsurpassed success history in recent European regulatory accomplishments. In 2009 NDA advised on 33% of all products approved centrally in the EU.

For over ten years NDA has been working together with clients to streamline drug development and ensure approvable and reimbursable outcomes. This ensures a fast and predictable market introduction saving significant costs, securing data/market exclusivities and effectively expanding the product's commercial window of opportunity. Ultimately this increased share holder value and improves the life of the patients.

Unmatched expertise and success

NDA has an unmatched expertise and success record in assisting clients with their market approval process. The NDA Advisory Board, comprised of some of Europe's most acknowledged regulatory experts, in part founders of the European regulatory system, provides strategic input on all levels of product development. Over 90% of the top 20 pharmaceutical companies rely on this expertise to ensure their products meet set targets.

For NDA the true measure of client satisfaction is seen in the statistics – 98% of NDA's clients become repeat customers.

The NDA Group works out of offices in key locations in Europe – Germany, Sweden and the United Kingdom. Taken together NDA's capabilities to facilitate a fast market introduction in Europe are unmatched in the world.

Expertise:

  • Development strategy
  • End-point selection advice
  • Submission strategy
  • Paediatric application strategy and planning
  • Risk management strategy and planning
  • Scientific Advice – CMC / pre-clinical / clinical issues
  • Full regulatory, quality assurance and pharmacovigilance support

NDA Advisory Board

Providing a unique and excellent service is impossible without unique and excellent individuals. The NDA Advisory Board boasts some of Europe's most distinguished regulatory experts, in part founders of the European regulatory system. This group provides clients with advice throughout the entire development and marketing authorization process to facilitate a swift market introduction.