Once your product is on the UAE market, you have ongoing safety reporting obligations under UAE pharmaceutical law. We operate the full pharmacovigilance system on your behalf, including the QPPV function.
Pharmacovigilance is not a document you file once. It is a living system that collects, assesses, and reports safety information for the whole time your product is on the market, with a named person accountable for it.
We run that system as one engagement, the QPPV and local contact, the master file, signal detection, case handling, and periodic reporting, so your safety obligations are covered without you building a department for them.
A single team across the QPPV function, case handling, and periodic reporting.
Pharmacovigilance system setup and PV Master File development, describing how your safety system is structured and run.
Adverse event reporting and case management, with structured intake, assessment, and processing of individual cases.
Periodic Safety Update Reports (PSURs) compiled and submitted to keep the safety profile of your product up to date.
Risk Management Plan (RMP) development, setting out how identified and potential risks are characterised and minimised.
Post-market surveillance and vigilance reporting for medical devices, monitoring safety and performance once on the market.
Field Safety Corrective Actions (FSCA) and recalls management, coordinated and reported when a product issue is identified.
Five stages, from standing up the system to ongoing reporting.
We provide the Qualified Person for Pharmacovigilance and the local point of contact for your products.
Build the Pharmacovigilance System Master File and the procedures that sit underneath it.
Collect, assess, and submit individual case safety reports within the required timelines.
Review safety data on an ongoing basis to identify and evaluate emerging signals.
Compile periodic safety reports and risk management updates, and act on findings.
Tell us about your products and where they sit in the UAE market. We will set up the QPPV function, the master file, and the reporting workflow, and run your post-market safety obligations end to end.
Talk to our PV team