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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.

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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Featured Expertise

Stay up to date

Get the latest news in drug development.

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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Dr Brian Edwards, MD

Principal Consultant

Expert in medical safety and pharmacovigilance

Expertise

Medical Safety & Pharmacovigilance

Medical support for regulatory teams

Pharmacovigilance audits for both EU and US legislation

 

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News & Events

Vaccine platform technologies – Learnings from the COVID-19 pandemic

NDA Advisory Board Members, Steffen Thirstrup and Pieter Neels provide an insight into current vaccine platform technology and how the rapid response to tackle emerging infectious diseases can be further improved.
2021-09-01

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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.

Let's Bring Medicines to the World