Pharmacovigilance is a vital practice in the development and distribution of pharmaceutical and healthcare products in monitoring adverse events.
Drug safety practices need to be carried out at each stage of the product life cycle to ensure that any adverse drug reactions don’t compromise the drug or treatment’s efficacy. Since the content is highly specialized, it’s imperative that all safety multilingual documentation is handled by certified linguists.
Backed by our 21 CFR Part 11-compliant technology, TransPerfect Life Sciences ensures timely and accurate safety notification letter distribution and GVP-compliant pharmacovigilance system master file (PSMF) management.
Regardless of where a clinical trial is being conducted or what language participants speak, TransPerfect can handle the processing, tracking, and reporting of adverse events in a timely manner. We also help sponsors expedite responses to regulatory authorities, such as for Periodic Safety Update Reports (PSUR) and Development Safety Update Reports (DSUR). A Structured Content Management System (SCMS), such as the one TransPerfect offers, can be transformational for PSURs and DSURs.