Quality & Compliance
Safety & Vigilance
11 october 2021
Context & challenge
Customers need to update old products dossier in accordance with Eurasian requirements. Both MW and RA competencies required
3 MW – 1 coordinator
On-Time-Delivery (OTD) and Right-First-Time (RFT) KPIs.
Both Medical writing and Regulatory experts acting in the same team: regulatory tasks (SmPC/PIL writing and readability tests) planned directly with the MWs.
Continuous improvement, with the objective to anticipate issues and implement or verify efficiency of action plans.
Our end-to-end global outsourcing model
PLG adaptability to customer evolutions with adaptation of the operating model, Workload evaluation, distribution, planning and forecast.
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