Regulatory consulting and services
Regulated processes
eCTD submission, Dossier outsourcing
EDMS and IT solutions implementation
Quality assurance
Pro-active safety
News |
Business CasesPV Information Systems: Validation Global Review Thursday 21 January 2010Preparing to archive documents (long term) Wednesday 13 May 2009Faced with the increasing size of their archives and the obligation for long-term storage of certain sensitive documents, laboratories are becoming interested in electronic archiving of documents and storing their paper documents under the best possible conditions. Data management: Analysis and extraction of data Tuesday 03 March 2009Achieving compliance with the European Paediatric Regulation requires the compilation of the paediatric effects described in the marketing authorisations for all the medicines. The highly demanding timetable has forced certain laboratories to create a veritable task force. Outsourcing electronic submission filing: From strategy to training, from consultancy to services Monday 02 March 2009How a dermatology company implemented eCTD while centralizing the management of publishing activities and outsourcing eCTD production Managing the development projects portfolio of an R&D organisation Monday 02 March 2009How an integrated resource management and project management system allows better allocation of resources and activities within the R&D Department. Document management: installation of validated platform Monday 02 March 2009How, using an R&D GED, a GED for the business was defined and put in place eCTD: Taking what exists and inserting into GED Sunday 01 March 2009The introduction of eCTD has helped overhaul document management Pharmacovigilance: Introducing a "proactive safety" step Sunday 01 March 2009ProductLife assists the Pharmacovigilance and Risk Management Departments in a major pharmaceutical laboratory, in the introduction of a process for preventing medical risks associated with pharmaceutical products. Variations: treatment in international context Friday 20 February 2009GED: Optimisation and introduction within an eCTD perspective Thursday 19 February 2009To preserve the eCTD resources and help GED to evolve in position. |
Focus
Outsourcing electronic submission filing: From strategy to training, from consultancy to services Managing the development projects portfolio of an R&D organisation |
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