Transforming Patient Safety: SOPROEN and JCP Regulatorios S.A.S. Launch Comprehensive Pharmacovigilance Web Application

SOPROEN successfully has developed a state-of-the-art pharmacovigilance web application for JCP Regulatorios S.A.S. This innovative solution is designed to enhance medication safety and ensure regulatory compliance for pharmaceutical companies across Ecuador.

Key features of the system include:

• • Automated Periodic Safety Reports (PSURs): Facilitates continuous monitoring of the risk-benefit profile of medications.

• • Risk-Benefit Analysis Tools: Enables detailed assessment and reporting of pharmaceutical products.

• • Scientific Literature Management: Organizes and stores relevant scientific literature for easy access.

• • Record Management: Allows controlled editing and secure record-keeping, with deletion privileges reserved for administrators.

• • Advanced Search Filters: Streamlines information retrieval by enabling searches by date, ID number, adverse reaction codes, and attachment names.

• • Unlimited Attachment Support: Enhances documentation capabilities for each case.

• Multi-Company Functionality: Tailors user access and permissions across different organizations.

This advanced web application not only reinforces JCP Regulatorios S.A.S.’s capacity to support pharmaceutical companies in meeting Ecuadorian regulatory standards—including Good Manufacturing Practices (GMP) certification and sanitary registrations—but also sets a new benchmark for technological excellence and professional oversight in the field of pharmacovigilance.