Business Cases

Monday 04 April 2011 Managing the portfolio of Raw Materials

Set up an in-sourcing solution in order to manage the Raw Material portfolio in terms of safety and selection optimisation.

Thursday 31 March 2011 Electronic Laboratory notebooks

Opportunity to implement electronic Laboratory notebooks.

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 Regulatory Affairs: Data Quality Management

The marketing of medicinal products in over 100 countries involves a rigorous und updated follow-up of the global Regulatory Affairs activity.

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 PV Information Systems: Validation Global Review

Global review and PV in formation Systems (IS) preparation to Health Authorities' planned inspection (AFSSAPS, MHRA).

Monday 07 March 2011 Pharmacovigilance: Setup of a Euro compliant PV system

In the scope of a BioPharma entity setup, support in the design, implementation and roll out of the PV system, worldwide and compliant with the European regulations.

Monday 07 March 2011 Preparation of long term archiving of documents

Having to cope with the increasing size of their archives and the obligation of long-term storage of certain sensitive documents, pharmaceutical companies are becoming interested in the electronic archiving of documents and the storage of their paper documents under the best possible conditions..

Monday 07 March 2011 Pharmacovigilance: Introducing a "proactive safety" step

ProductLife assists the Pharmacovigilance and Risk Management Departments of a major pharmaceutical laboratory, in the introduction of a process for preventing medical risks associated with pharmaceutical products.