Case Study

Removing New French Regulatory Burden through Document and Processing Expertise

Removing New French Regulatory Burden through Document and Processing Expertise

www.productlifegroup.com Page 1 of 2 C ASE STUDY Removing New French Regulatory Burden through Document and Processing Expertise ProductLife Group Takes on Template Development and Design Combined with Labelling Support THE CLIENT A United States–based company engaged primarily in the commercialisation of generic drugs and which has been the leader in the generic market in France for more than 15 years PROJECT SCOPE Faced with an additional regulatory burden, the client turned to ProductLife Group to manage new template requirements with regard to product information submitted in France. The requirements, issued by French regulatory authority Agence nationale de sécurité du médicament et des produits de santé (National Agency for Medicine and Health Products Safety, or ANSM), invo

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