Capabilities OverviewMajor Submissions

Major Submissions

The challenge

The submission of a major dossier is a key milestone for any medicinal product and 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, is therefore a critical priority for any drug developing company.

Our experts

The NDA Team consists of regulatory consultants with extensive experience of working within health authorities, the pharmaceutical industry or both through the submission process. This gives you access to key insights required to determine a clear way forward with a new product development in order to achieve a positive decision by the regulators. This is backed up by operational support from writers and publishing experts to compile and publish your submission.

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 40% of products recommended for approval in the EU between 2013-2016 being supported by NDA.

How we help

NDA is optimally placed to provide support for all key aspects of your submission process. This includes development of the optimal regulatory strategy, authoring and compilation of all sections of the dossier according to the CTD, as well as offering regulatory operations support with full publishing capability.

A selection of Our Major Submissions Experts