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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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.


Early Development

Late Development & Submission

Commercial Products


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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Featured Expertise

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Dr Laurie Smaldone Alsup

Chief Medical And Scientific Officer

Expert in clinical development and regulatory strategy



Rare genetic disorders

Infectious diseases – bacterial and viral


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Dr Steffen Thirstrup

Advisory Board Director

Expert in EU regulatory system and clinical/regulatory strategies


EU regulatory systems

Clinical pharmacology and therapeutics

Clinical development plan scientific strategy and design


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Dr Paula Salmikangas

Advisory Board Director

Expert in biological medicinal products


Scientific and regulatory knowledge of biopharmaceuticals and ATMPs

EU regulatory clinical documentation requirements

Scientific strategy and design


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Dr Tina Amini

Medical Device Division Director

Expert in medical devices regulations


Regulatory Expertise in EU Medical Device Regulation (MDR) and EU In-vitro Diagnostic Regulation (IVDR)

Borderline classification

Compliance and approval of combination products


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News & Events

Accelerated Approval strategies for Emerging Biotech

Dr Laurie Smaldone Alsup and Dr Steffen Thirstrup participated in the webinar – Accelerated Approval strategies for Emerging Biotech, which was a collaboration between NDA and The Conference Forum.

Get to know our experts – Andrea Pless

Today we shine the spotlight on Dr Andrea Pless. Andrea excels in supporting our clients through all stages in drug development with a focus on CMC.

Turning the page

In the current issue of Nordic Life Science Magazine, our CEO, Johan Strömquist shares his thoughts on the past year and what’s on the horizon for the life science sector in the Nordics.

Accelerated Approval – Making the right decision

In this second part of our two-article series, we explore the implications for development companies of FDA’s handling of these so-called ‘dangling’ approvals.

NDA webinar: Payer Negotiations – What are the challenges and how do you overcome them

In this webinar, Steffen Thirstrup and Carole Longson highlight the different viewpoints between the regulatory and HTA assessment to guide you on how best to prepare for a positive outcome in both assessments.

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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