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Adverse Event Report

Pharmacovigilance and sanitary surveillance 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.

Request pharmacovigilance advice
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What does our pharmacovigilance service include?

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.

Benefits of our pharmacovigilance management

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Prevention of sanitary risks

We detect and manage adverse events to protect patient safety.

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International regulatory compliance

We align your reports with WHO, EMA, FDA, and local authority standards.

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Traceable, auditable processes

Every report has verifiable documentary support and technical follow-up.

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Regional coverage

We implement pharmacovigilance and technovigilance programs throughout Latin America.

Comprehensive pharmacovigilance and sanitary surveillance process

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Pharmacovigilance system design

Initial assessment and definition of reporting processes.

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Event collection and recording

Continuous monitoring of products on the market.

3

Risk analysis and assessment

Classification of severity, causality, and frequency.

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Notification to competent authorities

Timely management in accordance with local regulations.

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Follow-up and continuous improvement

System updates based on new findings and audits.

Proven results in pharmacovigilance and technovigilance

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Regional active pharmacovigilance system

UBG implemented a continuous reporting system for a laboratory with a presence in six countries, optimizing traceability and regulatory compliance.

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Faster response to adverse events

Average response time was reduced by 45% through automation and documentary validation.

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Integration with health authorities

We achieved interoperability between internal platforms and regulatory agencies in Ecuador and Panama.

Strengthen your pharmacovigilance systems with sanitary compliance experts

Contact us to strengthen your pharmacovigilance system

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Contact Us
  • Ecuador: Mariana de Jesús E7-8 y La Pradera, Edificio Business Plus La Pradera, Of. 605, CP: 170518, Quito - Ecuador
  • +593 2 600 3014
  • info@ubg.com.ec
  • Panama: Calle 74, San Francisco, Edificio Midtown, Oficina 1805 - DELCO, Panama City, Panama
  • El Salvador: San Salvador Final 83 Avenida Sur, No. 403, Segundo Nivel, Colonia Escalón, San Salvador, El Salvador.
  • Terms and Conditions
  • Data Protection Policy
  • Adverse Event Report
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