PV Submissions

Decoding the Differences: ICH R3 vs EU R3 vs US FDA R3 in Pharmacovigilance Reporting

Pharmacovigilance reporting is a critical aspect of ensuring patient safety

Why a Modern Drug Safety Database is Key to Regulatory Success.

In the world of pharmacovigilance, staying compliant with ever-evolving regulatory

How Do Aggregate Reports in Pharmacovigilance Impact Drug Safety?

In pharmacovigilance, monitoring drug safety is an ongoing process that

Pooling meaningful data from vast Pharmacovigilance database for Regulatory periodic reports

There exist regional and universal guidelines emphasizing the type and

Mechanism to extract adverse experience reports output for US FDA

Periodic safety reports are prepared as a part of periodic

Solution to Periodic safety submissions (PADER/PAER reports) through eCTD submission software

The Regulatory industry is witnessing huge transformations. Some new regulations

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