Development Plans ...

With Europe having expanded to 25 countries Companies now have access to a larger market than ever before. Using the common technical document (CTD) dossier there is now an opportunity to make regulatory filings simultaneously in Europe and in the US. In order to take full advantage of this it is essential to ensure that the specific needs of both the EU and the US regulatory agencies are considered at an early stage in the development of a product and to ensure that development plans are devised that will ultimately satisfy the needs of both regions.

Shore has practical experience that enables them to offer sound advice and guidance on drug development programmes and their suitability for filing. We are able to assist in writing product development plans, protocols, investigator brochures and investigational medicinal product dossiers.

An early filing in Europe provides many benefits:
· The marketing group have access to a global market from the time of the product’s launch
· The commercial group have the possibility to make sales globally
· The regulatory group can make optimum use of the CTD dossier
· The legal group will see maximum benefit from patents

It is essential to take good regulatory advice at a very early stage in a product's development and Shore is ideally placed to offer this advice..