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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Dr Laurie Smaldone Alsup

Chief Medical And Scientific Officer

Expert in clinical development and regulatory strategy

Expertise

Oncology

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

Expertise

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

Expertise

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

Expertise

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

Get to know our experts – Dr Laurie Smaldone Alsup

Today, we shine the spotlight on Dr Laurie Smaldone Alsup, Chief Medical & Scientific Officer and learn why she's so driven to helping companies develop medicines that patients urgently need.
2022-05-26

The Quest for big data

In April's issue of MedNous, Dr Steffen Thirstrup shares some thoughts around big data and its essential use during the post-authorisation period.
2022-05-11

Get to know our experts – Christine Lind

Today, we shine the spotlight on our VP of Commercial, Christine Lind and learn about her passion for making a positive change in the world.
2022-04-27

Get to know our experts – Johan Strömquist

Today, we shine the spotlight on our CEO, Johan Strömquist, and learn about his journey in the industry and his thoughts on how to evolve and improve change.
2022-03-30

ACCESS work-sharing

Access Consortium is another pathway to global markets. International work-sharing enables a pharmaceutical company to file the same submission content in multiple jurisdictions and receive simultaneous review. Here's how..
2022-03-25

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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