Our Services
Regulatory Affairs
Helping you make the right decisions to ensure the safest and quickest path to approval for your product
Strategic communications
Bridging the communication gap between your team and the Regulatory Agencies
Quality & Compliance
Ensuring consistent quality by creating practices and systems tailored to your needs
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.
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.
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.
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.
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