PSUR Central – Global PSUR & PBRER Services
Scientific Compliance for Colombia’s Modernized Market: INVIMA | e-Reporting | ICH | GVP
PSUR Central, the specialized scientific arm of Zoesoe Exports Pvt Ltd, provides premium Periodic Safety Update Report (PSUR) and PBRER services tailored for the pharmaceutical, biological, and medical device sectors in the Republic of Colombia.
Colombia is currently executing a transformative "Regulatory Acceleration" under Resolution 2025010547, effective March 19, 2025. This mandate focuses on clearing procedural backlogs and mandating high-stringency pharmacovigilance (PV) for all Marketing Authorization Holders (MAHs). With the shift toward the e-Reporting web-based application, INVIMA now strictly enforces ICH E2B-R3 requirements, including mandatory MedDRA and WHODrug coding. Since 2008, we have supported global firms in delivering safety dossiers that satisfy INVIMA’s specialized review units.
Who We Support in Colombia
We provide specialized expertise across Colombia’s diverse health product landscape:
International Pharmaceutical Importers: Managing PBRER and PSUR cycles to ensure alignment with INVIMA’s 5-year registration validity and renewal windows.
Local Person Responsible for Pharmacovigilance (LPPV): Providing the technical scientific back-end required by Colombian physicians and pharmacists serving as LPPVs.
Biological & Biosimilar Innovators: Navigating the three regulatory pathways—Complete, Comparability, and Abbreviated—with safety data that meets Decree 1782 standards.
Medical Device & IVD Manufacturers: Complying with the February 2026 deadline for Class IIa/I devices and the current mandatory UDI-DI (Unique Device Identifier) reporting for high-risk products.
Clinical Trial Sponsors: Drafting Development Safety Update Reports (DSURs) for studies conducted under the oversight of INVIMA’s Directorate of Medicines and Biological Products.
Our PSUR & PBRER Services
Our scientific precision aligns with INVIMA’s goal of ensuring the safety, efficacy, and quality of products in the Colombian market:
e-Reporting & eCTD Compliance: Expert drafting of safety reports optimized for the e-Reporting system, utilizing ICH E2B-R3 XML standards.
PSUR/PBRER Preparation: Drafting reports according to the EURD list periodicity. While submissions are mandatory only upon request, we ensure they are "audit-ready" and available at all times.
Bilingual Technical Writing: Professional preparation of technical safety narratives in English or Spanish, including the mandatory Spanish translation of executive summaries.
Risk Management Plan (RMP) Support: Drafting RMPs for innovative medicines and biological products, required for both new registrations and renewals.
Signal Detection & Analysis: Utilizing scientific methodologies to assess safety signals from the National Pharmacovigilance Centre and global platforms like VigiBase.
Why Pharma Leaders in Colombia Choose PSUR Central
"Scientific rigor to power Colombia’s digital and accelerated regulatory future."
2025 Acceleration Specialists: We are fully operational under the Resolution 2025010547 Contingency Plan, ensuring your safety updates are submitted without technical friction.
Specialized Review Unit Alignment: Our reports are structured to meet the specific requirements of INVIMA's specialized "cells" (working groups) tasked with risk assessment.
Local Language & Global Data: We bridge the gap between global English safety data and the Spanish language requirements essential for Colombian clinical and regulatory reviews.
Science-Led Quality: Every report is scrutinized by medical experts to ensure the safety profile is scientifically defensible and clinically robust.
Regulatory Standards Followed
Our documentation is meticulously prepared in alignment with:
Resolution 2025010547 of 2025: The regulatory acceleration and contingency plan for pharmaceutical procedures.
Decree 677 of 1995 & Decree 1782 of 2014: The foundational laws for drug and biological product registration.
ICH E2C (R2) & E2B (R3): The international gold standards for periodic reporting and electronic data transmission.
INVIMA Pharmacovigilance Guidelines: The national framework for ICSR, PSUR, and RMP management.
Get Started: Partner With Us
To initiate a customized project for your operations in Colombia, we typically require:
Product Portfolio and classification (Pharmaceutical Class A, B, C, or Biological).
LPPV Coordination: Contact details for your appointed Local Person Responsible for Pharmacovigilance.
Approved Labeling: The SmPC (Summary of Product Characteristics) and the Spanish-language Patient Leaflet.
Local Safety Data: Summary of serious and non-serious ADRs reported via the e-Reporting portal.
Submission Calendar: Coordination with your 5-year renewal cycle or specific INVIMA requests.
Contact PSUR Central today to ensure your pharmaceutical safety compliance in Colombia is authority-ready and scientifically robust.
Global PSUR Compliance. Science-Driven. Authority-Ready.