Our services span the entire lifecycle of a drug, from pre-clinical right through to post marketing and cover all regulated areas: Regulatory Affairs, Pharmacovigilance, Quality and HTA.
We can assist with all or parts of a project, providing top-level strategic advice, through to hands-on delivery and support across all therapeutic areas.
See how NDA can assist you in your stage of the product lifecycle by clicking the phases above.
From the early stages of development, through to the maintenance of a product successfully established in the market, access to high quality regulatory advice and competent support is critical to the success of any life science company.
Through NDA’s Advisory Board you get access to advice that reflects the current practices and opinions of the European and US regulatory agencies better than anyone else in the world. Through NDA’s consulting services you will successfully deliver high quality regulatory filings, and ensure that your products are maintained on the market in accordance with all regulatory requirements.
High-stakes Meeting Preparation
At critical lifecycle milestones, such as CHMP Oral Explanations, FDA Advisory Committees or payer negotiations, your product’s future may be at stake. Preparing to present and defend your product at a meeting with decision-makers is a major challenge for any team. Achieving success in these venues requires a clear strategy and focused preparation. Your company needs to deliver a clear and compelling argument supporting your position, and be ready to respond confidently when challenged.
At NDA we’ve brought together unmatched expertise covering the scientific, regulatory, payer as well as communication expertise required to tailor a service that will give your team the best chance your data permits when engaging in high-stakes meetings. With the help of our proven approach, experienced teams and customized tools and techniques we have helped hundreds of teams succeed since the late nineties.
Today we focus our line of services on a number of critical milestone meetings, ranging from FDA Advisory Committees and European Oral Explanations, to payer negotiation preparation. In addition we create tailored solutions to support many other kinds of health authority interactions and commercial milestone meetings.
Understanding and managing the risks and quality of a pharmaceutical product has never been more important than it is today. Ensuring this is done in an efficient and cost effective way, supported by the right expertise, process and systems, is critical to your success.
NDA’s integrated Pharmacovigilance and Risk Management Services give you a comprehensive view of the clinical safety and quality requirements throughout the entire life cycle of your product. This ensures that you manage risk in an efficient way, aligned with the new pharmacovigilance legislation, whilst monitoring your products to effectively deal with any potential concerns that may arise.
HTA (Health Technology Assessment)
Regulatory approval is no longer sufficient to ensure market and patient access to medicines. HTA and health economic considerations are emerging as significant requirements on the road to market.
In an environment where all European member states have their own individual systems and requirements, getting an overview of what is needed for good medicines to reach the patients is becoming increasingly difficult.
One way to meet this increasing need for knowledge and information is to gain input from the most experienced individuals in the field. At NDA, we have brought together some of the leading minds in the field of Health Technology Assessment in Europe to support clients with any HTA or health economics challenge in Europe.