Data Management news

ASPHALION SERVICE “MINI PILL” | RIM system

Regulatory Information Management (RIM) system is a vital element of any regulatory strategy, since it allows processes and data governance optimization. RIMs are becoming even more essential with the upcoming ISO IDMP implementation, as it offers “directed” solutions to comply with the standards and regulations.

ISO-IDMP O EL CAMBIO DE PARADIGMA EN LA INDUSTRIA FARMACÉUTICA

La Agencia Europea del Medicamento (EMA) ha comenzado la implementación de los estándares desarrollados por la Organización Internacional de Normalización (ISO, del inglés International Organization for Standardization) para la identificación única de medicamentos (IDMP, del inglés Identification of Medicinal Products).

2nd eAF (DADI) Newsletter has been published on the EMA website!

2nd eAF (DADI) Newsletter has been published on the EMA website: The web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) – often referred to by its former project name, DADI – has been available for use as of 4 November 2022 on the new Product Lifecycle Management (PLM) Portal.

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