Let's bring medicines to the world
Because the world is waiting

NDA is a leading regulatory drug & device development consultancy, supporting companies with their regulatory, pharmacovigilance, quality and strategic communication challenges across the US and Europe. 

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Our Services

Phases of Development

From Concept To Commercialization

Click on the timeline to learn more about how we can support you on your product’s journey.

Pre-Clinical

Early Development

Late Development & Submission

Commercial Products

Pre-Clinical

From fund-raising through regulatory interactions and preparation for your first in human trials, the regulatory aspects of drug development add value to your asset. Defining your road to market and utilizing regulatory milestones to demonstrate the value of your product, are some of the opportunities that we at NDA support to make you successful.

Find out about the challenges and solutions in the pre-clinical phase.

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Early Development

Supporting your indication selection and assessment of different acceleration strategies are part of what we do exceptionally well at NDA. We help you maximise the value of your asset based on the data you already have and the regulatory and market opportunity that can be leveraged. Paediatric and orphan drug strategies are second nature to us, just like getting your trial approved.

Find out about the challenges and solutions in the early development phase.

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Late Development & Submission

Entering into the costliest phase of drug development requires a strong foundation – a foundation that we at NDA have been testing and vetting for hundreds of companies. Once the course is set, preparation for filing commences – the largest regulatory challenge your product has yet to face. Do you want your product approved in the US and the EU? NDA is here for you.

Find out about the challenges and solutions in the late development & submission phase.

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Commercial Products

As your product approaches approval, the NDA team stands ready to support your product launch into multiple jurisdictions. Some of the world’s most prominent brands have been supported by our team, ensuring efficient regulatory compliance and creative development strategies for those assets that are generating true value for patients and for your company.

Find out about the challenges and solutions in the commercial products' phase.

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News & Events

Get to know our experts – Ricarda Meincke

In this article, we shine the spotlight on Ricarda, a consultant at NDA, and learn how she took the plunge into regulatory affairs.
2022-07-12

De-risking cell and gene therapy development

How do you prepare a regulatory roadmap with a combined EU/US regulatory strategy to manage risks and uncertainties linked to these scientifically advanced products?
2022-06-30

Get to know our experts – Finn Pulfer

Today, we shine the spotlight on Finn Pulfer, a regulatory consultant at NDA, and learn what led him down the pharmaceutical path and, eventually into regulatory affairs.
2022-06-27

Where to go and what to do – how drug development and approval strategies can meet the regulations and reimbursement requirements.

Approaching different regulatory agencies in parallel could be a challenge yet achievable. Learn how to make the most of what you have and make your value story work across different jurisdictions.
2022-06-22

The feeling of being run over

In September 2019, at the age of 54, Claes Buxfeldt was diagnosed with Amyotrophic Lateral Sclerosis (ALS). Here he shares his story.
2022-06-14

Contact Us

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.

Let's Bring Medicines to the World

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