
Prevention of sanitary risks
We detect and manage adverse events to protect patient safety.
At UBG Regulatory Advisors we implement comprehensive pharmacovigilance and technovigilance systems to monitor the safety, efficacy, and quality of products on the market.
We help our clients meet national and international regulatory guidelines, ensuring timely reporting and full compliance with health authorities.
Pharmacovigilance makes it possible to detect, assess, and prevent adverse effects or problems related to the use of medicines and medical devices.
At UBG we design tailored programs that strengthen our clients' internal systems, optimize information collection, and ensure the traceability of every case.
Our experts apply international methodologies (WHO, ICH, EMA, FDA) and work with local teams to ensure active, efficient surveillance in accordance with current sanitary regulations.
We detect and manage adverse events to protect patient safety.
We align your reports with WHO, EMA, FDA, and local authority standards.
Every report has verifiable documentary support and technical follow-up.
We implement pharmacovigilance and technovigilance programs throughout Latin America.
Initial assessment and definition of reporting processes.
Continuous monitoring of products on the market.
Classification of severity, causality, and frequency.
Timely management in accordance with local regulations.
System updates based on new findings and audits.
UBG implemented a continuous reporting system for a laboratory with a presence in six countries, optimizing traceability and regulatory compliance.
Average response time was reduced by 45% through automation and documentary validation.
We achieved interoperability between internal platforms and regulatory agencies in Ecuador and Panama.
