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Regulatory consulting and services

Regulated processes

eCTD submission, Dossier outsourcing

EDMS and IT solutions implementation

Quality assurance

Pro-active safety

 



 

News

Business Cases

PV Information Systems: Validation Global Review Thursday 21 January 2010

Preparing to archive documents (long term) Wednesday 13 May 2009

Faced 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 2009

Achieving 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 2009

How 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 2009

How 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 2009

How, 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 2009

The introduction of eCTD has helped overhaul document management

Pharmacovigilance: Introducing a "proactive safety" step Sunday 01 March 2009

ProductLife 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 2009

GED: Optimisation and introduction within an eCTD perspective Thursday 19 February 2009

To 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

eCTD: Taking what exists and inserting into GED

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