NDA Group

NDA Group

Silver Partner

Objective, impartial advice tailored to your needs
We are an independent, private, family-owned business solely focused on giving pharmaceutical companies objective, impartial advice on how to accelerate patient access to important medical therapies.

With NDA you will work with a single partner linking science, medicine, regulation and reimbursement considerations to optimise development timelines.

Reduce your time to market
We take an independent view of your product development and advise on what needs improving, amending or shaping. We will steer you on what the regulators are looking for, how to best present your data, how to prepare your submission and documentation. You will have a well-defined path and direct guidelines that will optimise your development activities and help you focus on what is needed to get your drug approved and to market faster.

Keep your drug on the market
Once on the market, you need to keep tracking and monitoring the safety and efficacy of your drug, prepare for potential audits and reviews and maintain your product through variations, label changes, etc.

Planning for post market requirements starts right back in drug development. We can support you in building this into your development plans, or work with your post authorisation plans to keep your drug on the market with minimal process and cost.

Ensuring the right clinical program with the right end-points, taking all regulatory and payer requirements into account, saves you vast amounts of money. We focus on helping you to showcase your new medicine in the best light to the ultimate benefit of patients.

Our mission
NDA’s sole commitment is to make sure that the best possible medicines reach the market without unnecessary delay and ensuring that they remain there for as long as they benefit the patients.

We achieve this by providing our clients with an extensive portfolio of services that are optimised to meet the standards of regulatory authorities and reimbursement agencies. You will benefit from our comprehensive and qualified input into development plans and regulatory assistance throughout the life span of their products, thus ensuring rapid access to market and efficient maintenance during the entire product life cycle.

We bridge the communication gaps between the different stakeholders and departments within our clients, as well as between the regulated and the regulators for the ultimate benefit of patients.

At NDA we consider our mission to be at the core of what we bring to our clients, but also of what we bring to society. Our mission is also embedded in the way we conduct ourselves and our business. Communicating and explaining what our mission means to each and every one at NDA is critical to make sure it becomes more than just a couple of phrases. For that purpose, we have established the NDA Code of Ethics.

https://ndareg.com/ 

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