Pharmacovigilance
Comprehensive Pharmacovigilance Solutions
An effective pharmacovigilance system is essential to ensuring patient safety and maintaining regulatory compliance.
We work with pharmaceutical companies to establish, maintain, and strengthen their pharmacovigilance activities throughout the product lifecycle.
Our Services
Local QPPV Services
Provision of experienced and qualified Local Qualified Persons for Pharmacovigilance (QPPVs) to support Marketing Authorization Holders in fulfilling their regulatory pharmacovigilance obligations, maintaining compliant pharmacovigilance systems, and serving as the designated local contact with regulatory authorities.
Adverse Event Reporting
We support the collection, documentation, and reporting of adverse events, adverse drug reactions, medication errors, lack of efficacy, and product safety concerns to local authorities.
PSUR & PBRER Submission
We assist with the review and submission of Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation Reports, in line with local authority's timelines and safety reporting requirements.
Risk Management Plan (RMP) Submission
Preparation, adaptation, and submission of Risk Management Plans to support product registration and lifecycle management.
Pharmacovigilance Training
We provide tailored PV training for distributors and healthcare teams to strengthen safety reporting, regulatory compliance, and inspection readiness.