The submission and review of a major dossier is a key milestone as well as a challenge for any pharmaceutical company. A negative outcome can be detrimental not just to the product, but to the commercial success of the whole business. Ensuring that your submission is managed optimally, from strategy and key messaging, through to the operational filing and authority engagement during review, is therefore a critical priority for any drug developing company.
Our team of clinical experts cover the majority of therapeutic areas, from very rare diseases to the most common conditions, with hands-on experience in clinical settings. NDA clinical experts are not only extremely knowledgeable about their therapeutic field, but can also provide insight to the EU/US regulatory requirements that goes beyond reading the most recent regulatory guidelines. This combined clinical-regulatory expertise can help you get your messages across when writing regulatory submission documents or when engaged in addressing regulatory questions be it in writing or at oral explanations/hearings
Our track record
NDA has managed the successful delivery of more than ten EU Marketing Authorisation Applications, just over the last two years. In addition we supported close to 100 additional major submissions over the past five years, including NCEs, line extensions and OTC switches. Our track record is unmatched in industry with over 50 % of products recommended for approval in the EU in 2015 being supported by NDA.
How we help
With NDAs support, we can assist in identifying the areas in the majority of clinical developments that would be ‘sensitive’ to EU/US regulators and therefore would need particular attention.