;   Medical Translation Insight: QRD compliance just got easier thanks to QRDetect - ForeignExchange Translations

QRD compliance just got easier thanks to QRDetect
In order to gain simultaneous market authorization in all European Union (EU) member states as well as Iceland, Lichtenstein and Norway, global pharmaceutical companies must submit regulatory dossiers to the European Medicines Agency (EMA) by means of the centralised authorization procedure (CP).

EMA has set up strict guidelines in terms of terminology and stylistic and formatting requirements to enable the Quality Review of Documents (QRD), and demands full compliance with these requirements prior to granting its opinions.

ForeignExchange, through its partnerships with a number of large pharmaceutical clients, identified the need to develop a tool to partly automate the QRD control in order to ensure full compliance to facilitate and speed up the drug approval process. The tool, called, QRDetect™ has proven to speed up the document QC process by up to 75% and ensure compliance with EMA regulations. We’ve prepared a case study about QRDetect™. Download it here to read more:


ForeignExchange Translations provides specialized medical translation services to pharmaceutical and medical device clients. Contact us to find out why our clients rave about us!


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