Multiple challenges are facing today’s pharmaceutical and biotech companies. Development costs are mounting, success rates are dropping, regulatory and political pressure is increasing – all impacting success. Working in a cost effective way, whilst keeping a development plan on track and driving your drug to market first, is a real challenge. Getting independent strategic advice early on can help steer you on the right track, ensuring you have the right drug in development, the right data and trials in progress, the right information presented in the right way for the regulators, and then the payers. Getting it right is the difference between success and failure for your drug, and your business.
The NDA Advisory Board brings together some of the most prominent experts in regulatory affairs, pharmacovigilance and HTA. All are ex-regulators or senior industry leaders, renown for the contribution they’ve made to drug development throughout their careers. Together, they give strategic insights unobtainable anywhere else, to help define the best development path to steer your drug to approval. Whether for independent reassurance and guidance to give you the best possible preparation in facing regulator and payer review, or to firefight a challenging situation.
Our track record
We’ve worked with 80% of the top 20 pharma companies, 65% of the top 20 biotech companies, and over a large number of small and medium sized drug development companies to advise on what’s needed to get their drug to market. Our advice is open and honest and we are not afraid to speak out and say the controversial. In 2015 alone, over 50% of products recommended for approval in the EU were supported by NDA.
How we help
An individual, group or expert panel from the NDA Advisory Board are cherry-picked based on your needs to support you wherever you are in your development phase, therapeutic area or requirement. This includes direction during the early stages of development, guidance in optimizing your dossier, preparation for regulatory review and associated meetings including handling challenging questions, oral explanations/hearings as well as commitments.