Aggregate reports
Our experience medical writer can help in preparation of clinical trial and post-marketing aggregate safety reports such as Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Report (PBRER), bridging reports, Periodic Adverse Drug Experience Reports (PADER), Annual safety reports (ASR)s and country specific aggregate reports as per local regulatory requirements.
Labelling and reference safety information (RSI)
With evolving stringent regulations regionally, labelling document establishment and maintenance has become mandatory. Our medical writers have hands on experience in CCDS preparation and update, Package Inserts (prescribing information) and Patient Information Leaflets; or any update of particular sections (PLLR) of RSI according regulatory changes.