Understanding the complexities surrounding the EU regulatory requirements and how to implement them plays a critical role throughout the development and ongoing maintenance of any new drug.
By getting it right, first time, and having an experienced team to hand to give you high level strategic advice and support to keep you on track, greatly increases your product’s chances of getting to market and reaching patients.
The NDA team has hands-on and in-depth experience across all therapeutic areas and all stages of a drugs development. We understand how to incorporate the EU regulatory requirements into your development plan, taking an impartial and independent view, helping you to focus on the right activities and end-points to assist you in gaining EU regulatory approval.
We understand how the EU differs from other regulatory requirements in N. America, Oceania and Asia, and can give you practical support to gain approval for your product in Europe. Or if you already have a presence in Europe, we can become an extension to your team to get your product to market and keep it there.
Our aim is to help you to save time, costs and resources and increase your chances of success.
How NDA can support you
NDA can assist you with any regulatory requirement across the product life cycle, no matter how small or large. Our consulting team can support you with product development strategy for your entire pipeline throughout clinical development and following approval of your product. Our experts will also support you in delivering high quality regulatory filings, help prepare you for Agency hearings and review your submission to give you a clear view on questions that may arise during Agency review, right through to ensuring that your products are maintained on the market in accordance with all regulatory requirements.
We can assist you with CMC (Quality) development, manufacturing changes and comparability, new market introductions, renewals and variations. During clincal development NDA experts can support you with the review of efficacy, safety & immunogenicity data.
Our team can support you in finding new opportunities for your approved products through alternative options like switching to Over-the-Counter (OTC) designation or advising on including new indications or routes of administration. Once on the market, we can provide hands-on support as needed to keep your product available to patients.