Pharmacovigilance Quality Assurance Support

Ensuring Compliance, Safety, and Regulatory Confidence

Pharmacovigilance is the backbone of patient safety and regulatory compliance. Global health authorities impose strict Good Pharmacovigilance Practices (GVP) to ensure accurate safety data collection, reporting, and risk management. A robust pharmacovigilance system isn’t just about avoiding findings—it’s about protecting patients, ensuring compliance, and maintaining trust in your products.

With evolving regulations and increasing scrutiny, companies must ensure their pharmacovigilance operations are audit-ready, efficient, and fully compliant. Biomapas helps clients achieve this through expert-led audits, risk-based quality programs, and end-to-end compliance support.

We apply a risk-based approach to pharmacovigilance auditing and compliance, ensuring that our clients proactively identify and mitigate risks before they escalate. Our senior auditors and EU Qualified Persons for Pharmacovigilance (QPPVs) bring extensive experience in global PV operations, regulatory inspections, and compliance strategies.

We provide a full spectrum of Pharmacovigilance Quality Assurance services, including:

Audits & Compliance Assessments

• Full PV System Audits – Assessing client/vendor SOPs, training programs, and PSMF compliance.
• Local PV System Audits – Evaluating adherence to regional PV regulations and reporting accuracy.
• GVP Process Audits – Reviewing literature monitoring, ICSR handling, and database management.
• Marketing Authorization Holder (MAH) Affiliates’ PV Audits – Ensuring global alignment and compliance.
• License Partner PV Audits – Verifying the accuracy and compliance of license partners’ safety data.
• Vendor & Distributor Audits – Assessing third-party safety data management and reporting practices.

Inspection Readiness & Training

• Regulatory Inspection Preparation – Mock inspections, gap analysis, and response development.
• Interview & Coaching Sessions – Training staff to confidently handle regulatory inspections.

PV Quality Management System (QMS) Development

• Tailored QMS Development & Maintenance – Designing pharmacovigilance QMS frameworks to support compliance and operational efficiency.

Partner With Biomapas

With a strong track record in global pharmacovigilance compliance, Biomapas delivers expert guidance, independent assessments, and hands-on support to keep your PV operations audit-ready and aligned with regulatory expectations.