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Services
Regulatory data for the Product Quality Review
The annual filing of regulatory data for the Product Quality Review (PQR) has become a requirement since January 2006. Product Supply releases product only in accordance with the approval system in the respective country, so the required data are available within the company. Nevertheless, the data are scattered over the company and are of differing quality and therefore incompatible for IT solutions. Big efforts – costing, time and resources – have to be undertaken to consolidate the data accordingly.
Clear workflows and an appropriately designed environment for capturing and controlling regulatory data save time, capacity and costs.
Our services include
- Development of workflows for capturing regulatory data
- Supporting management in making the flow of regulatory data cope with GMP requirements and fit for Product Supply's requirements
- Assistance in implementation with consulting, coaching and quality control.