Protect patients, meet regulatory obligations, and maintain product safety with expert pharmacovigilance support. At Althian, we provide specialized regulatory services to help sponsors, CROs, and pharmaceutical companies comply with local pharmacovigilance requirements across Mexico and Latin America. Our team ensures that all safety-related activities—from adverse event reporting to periodic safety updates—are handled with precision, timeliness, and full regulatory alignment.

Periodic Safety Update Reports (PSURs)

• Preparation and submission of PSURs in accordance with local and international guidelines (ICH E2C).

• Integration of clinical data, post-marketing surveillance findings, and global safety signals.

• Coordination with regulatory authorities to ensure timely review and feedback.

Risk Management Plans (RMPs)

• Development and localization of RMPs tailored to the product’s safety profile and regional requirements.

• Identification of safety concerns and implementation of risk minimization measures.

• Submission and updates aligned with COFEPRIS and other LATAM agency expectations.

Adverse Event Reporting

• Collection, documentation, and submission of Individual Case Safety Reports (ICSRs) for clinical trials and marketed products.

• Real-time monitoring and reporting of serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs).

• Compliance with local timelines, formats, and pharmacovigilance portals.

Safety Data Management & Regulatory Liaison

• Ongoing surveillance of safety data and signal detection activities.

• Acting as the point of contact with health authorities for safety-related queries and inspections.

• Support for pharmacovigilance audits and documentation readiness.