Pharmacovigilance
Comprehensive Pharmacovigilance Solutions
A strong pharmacovigilance system is essential to ensure patient safety and regulatory compliance.
We support pharmaceutical companies in establishing, maintaining, and strengthening their pharmacovigilance activities throughout the product lifecycle.
Our Services
Local QPPV Services
Provision of experienced Local Qualified Persons for Pharmacovigilance (QPPVs) to support Marketing Authorization Holders in meeting regulatory obligations, maintaining compliant pharmacovigilance systems, and serving as the local contact with regulatory authorities.
Adverse Event Reporting
Support for the collection, documentation, and reporting of adverse events, adverse drug reactions, medication errors, lack of efficacy, and other product safety concerns.
PSUR and PBRER Submission
Review and submission of Periodic Safety Update Reports and Periodic Benefit-Risk Evaluation Reports in accordance with regulatory authority requirements and timelines.
Risk Management Plan Submission
Preparation, adaptation, and submission of Risk Management Plans to support product registration and lifecycle management.
Pharmacovigilance Training
Tailored training for distributors and healthcare professionals to strengthen safety event reporting, regulatory compliance, and inspection readiness.