Case Study

ProductLife Group Provides Global Outsourcing for French Client ahead of Regulatory Mandate

ProductLife Group Provides Global Outsourcing for French Client ahead of Regulatory Mandate

www.productlifegroup.com Page 1 of 2 C ASE STUDY ProductLife Group Provides Global Outsourcing for French Client ahead of Regulatory Mandate Flexibility and Cross-Functional Support Key to eCTD Baseline Success THE CLIENT A French generic medicines company with a large and diverse product portfolio PROJECT SCOPE The client turned to ProductLife Group for building its consolidated dossiers in electronic Common Technical Document (eCTD) format to cover its portfolio of products, including many that have been on the market for years and therefore were submitted using old procedures. The objective is to ensure the company will be ready to meet requirements stipulating that marketing authorisation holders have complete dossiers in their databases and that they submit all variation fil

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