From serendipity to discipline

There are as many stories of humble beginnings as there are drugs on the market. Something originating in a test tube eventually became a multi-billion-dollar business. But although discovery is often serendipitous, drug development requires clear objectives, a stringent strategy and disciplined execution to deliver on the product’s full potential. At NDA we’ve supported companies for over 20 years ensuring that the path they are on is the right one.

In the early stages we advise on the best way to translate your pre-clinical findings into your very first human study, working out the right approach from the data you’ve accumulated. Our experts support you with clinical advice based on a solid regulatory perspective to select the right indication and the endpoints to go with it, including how to approach experimental biomarkers or different comparators, including real-world data.

Optimising the value of your asset

As your program moves forward and your target population becomes increasingly well defined, we help you assess the feasibility for orphan drug designations and how this can benefit your program. We help you design and get regulatory endorsement for the right paediatric strategy, something particularly relevant to the growing cell and gene therapy areas. At this stage we work closely with you to assess any opportunities for regulatory acceleration available in the US and in Europe.

Often, we capture all of these different steps in a regulatory roadmap to give you a clear view of the activities ahead and the optimal timeline that you can aspire to. Together with a strong Target Product Profile and Risk Management Planning, this gives you more than documentation – it gives you clarity around your intent, the potential of your product, clinically and commercially, and a path to overcome the challenges that you will be facing in your program.

Taken together, these activities all have the potential of significantly increasing the value of your asset in the eyes of a partner, while taking you meaningful steps closer to a marketing authorisation, potentially shaving months off your timeline.

Prepare for success

With a clinical proof of concept in hand you’ll embark on the most costly and risky part of your program – a confirmatory trial. Our Joint Advice services help you secure that your program is setup in the most appropriate way to satisfy the needs of both regulators and payers. Through the NDA Advisory Board, you get insights from the people who built the regulatory and payer systems, ensuring you have the right expectations and design the right program to meet theirs.

During this phase we support you in the careful formulation of your final label, and the necessary regulatory negotiations. This crucial step will ultimately define how your product will be used in the market and, if overlooked, can erode the potential of your product to reach all the patients that need it and the financial objectives that you’ve set for it.

Reaching the market is a major milestone – but the journey is far from over. We support your lifecycle strategy, be it planning for those necessary major variations or manufacturing changes, supporting the expansion of your indication or considering alternative commercial strategies, like switching your product Over The Counter.

Across the development life cycle, NDA is there for you, your team and your product. With our support you know that you are developing your product to meet its full potential, regardless of the challenges. We help you develop with the end in mind.

Our services include
  • Regulatory Roadmap
  • Joint Advice
  • Paediatric (PIP) Strategy
  • Orphan Drug Designation (ODD) Strategy
  • Acceleration Strategy
  • Indication Selection
  • Risk Management Plan
  • Target Product Profile (TTP)
  • Labeling Strategy
  • Due Dilligance
  • Biomarker Selection
  • Translational Strategy
  • Pipeline Review

Our Services

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Your drug development needs are unique

Contact us to learn how our experts can support you to meet all regulatory, quality and safety requirements and ensure the best path to approval.

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