Pharmacovigilance

Pharmacovigilance and Drug Safety services for patient safety

Our expert teams ensure safety from clinical development to post-marketing, combining global expertise with local insight. We deliver end-to end vigilance solutions to support compliance and patient protection.

Aixial’s achievements & specialties

Experienced team in Pharmacovigilance Cosmetovigilance

From early phase clinical development through to post-marketing

Regulatory compliance & Operational excellence

Protecting patient safety, ensuring regulatory excellence

At Aixial Group, we deliver end-to-end pharmacovigilance solutions designed to ensure patient safety, regulatory compliance, and operational excellence. Our integrated approach combines expert-driven services, advanced technologies, and proven methodologies to support pharmaceutical and biotech companies across the entire safety lifecycle.

What we deliver

Comprehensive safety services

We support the full pharmacovigilance lifecycle with high-quality, compliant deliverables:
Literature surveillance & signal identification
End-to-end case management (ICSRs)
Periodic safety reports (PSUR, DSUR, PBRER)
Risk Management Plans (RMP)
Signal detection & monitoring
SDEA management
Medical information handling
Inspection & audit support

Expert team in Pharmacovigilance

With an average of 24 years of experience for each team member, we have successfully provided services to over 160 studies across the US and Europe. We have strong local and global coverage with involvement in product approvals, including processes from early phase to NDA, and expertly managing EU CT safety submissions with a focus on regulatory compliance.