Background to NDA
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 our clients work with a single partner linking science, medicine, regulation and reimbursement considerations to optimise development timelines. Our experts supported the development of the regulatory and reimbursement systems in place today.
- NDA has no clinical research arm and therefore no interest in driving unnecessary clinical research – we only focus on what you need and what the regulators and payers require.
Help cut your development costs
By focusing your attention on what’s needed to get your drug approved by the regulators, and the data required by the payers, we’ll help you optimise your whole development program, cut out unnecessary clinical trials, and make you aware of any additional requirements.
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.
Help reduce your time to market
We take an independent view of your product development and advise on what needs improving, amending or shaping. We’ll steer you on what the regulators are looking for, how to best present your data, how to prepare your submission and documentation, and at the same time you will gain an understanding of what the payers and HTA bodies require.
You’ll get a clear path and direct guidelines from an independent and trusted source. Together, this will optimise your development activities and help you focus on what’s 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.