Assistance for Dossier preparation, production, submission and maintenance

Wednesday 16 March 2011 Outsourcing electronic submission filing: From strategy to training, from consultancy to services

How a dermatology company implemented eCTD while centralizing the management of publishing activities and outsourcing eCTD production.

Friday 11 March 2011 eCTD : into an EDMS

Introducing eCTD format helped the global document management evolution.

Monday 07 March 2011 Variations: management in international context

Preparation of an important number of variations dossiers in an in-sourcing configuration on the Customer site.

Monday 07 March 2011 Document management: installation of validated platform

How to define and launch a global EDMS, starting from the R&D’s EDMS.

Friday 04 March 2011 EDMS : Optimization and introduction within an eCTD perspective Client

To preserve the eCTD legacy and support evolution of the actual EDMS.

Friday 04 March 2011 Change management: Preparation of documents and dossiers for regulatory submissions

To adapt the business process and tools to comply with Regulatory Submission regulation updates and to increase document preparation and management efficiency.

Friday 04 March 2011 Data management: analysis and extraction of data

Achieving compliance with the European Pediatric Regulation requires the compilation of the pediatric effects described in the marketing authorizations for all the medicines. The highly demanding timetable has forced certain laboratories to create a veritable task force.

Friday 04 March 2011 Clinical Trial Application: preparation, submission and tracking

Support to the preparation, submission and tracking of the Clinical Trial Applications (CTAs) for a multinational company.