Pharmacovigilance Services

we offer comprehensive pharmacovigilance services designed to meet both international standards and the specific regulatory requirements of Latin American countries. Our mission is to support pharmaceutical companies, CROs, and healthcare organizations in ensuring patient safety through efficient adverse event monitoring, timely regulatory reporting, and robust risk management practices. With a strong understanding of local regulations and global compliance frameworks, we help our clients maintain vigilance throughout the product lifecycle—from clinical trials to post-marketing surveillance.

Adverse Event Collection and Case Management

We manage the end-to-end process of collecting, assessing, and reporting adverse drug reactions (ADRs), including serious and unexpected adverse events (SUSARs) from clinical trials and post-marketing sources. Our team ensures timely submission to the relevant health authorities and maintains full regulatory compliance.

Signal Detection and Risk Evaluation

Using validated methodologies, we perform ongoing signal detection and benefit-risk assessments to identify emerging safety concerns. We support clients in making informed decisions on risk minimization, labeling updates, and regulatory strategy.

Regulatory Inspection Readiness and QPPV Support

We assist sponsors and MAHs in preparing for pharmacovigilance audits and inspections by local regulatory authorities. We also offer Qualified Person for Pharmacovigilance (QPPV) services through a network of local experts to fulfill country-specific requirements.

Local Literature Monitoring and Regulatory Reporting

We conduct routine surveillance of local scientific and medical literature to identify safety signals and case reports, ensuring compliance with national pharmacovigilance requirements. We handle health authority notifications in countries such as Colombia (INVIMA), Mexico (COFEPRIS), Chile (ISP), and beyond.

Preparation of Safety Reports (PSURs, RMPs, DSURs)

We develop and submit Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and Development Safety Update Reports (DSURs), in accordance with ICH, EMA, and local Latin American standards—supporting transparency, traceability, and global safety compliance.

Clinical Trial Safety Monitoring

We provide pharmacovigilance support throughout the clinical development lifecycle, including SAE reconciliation, safety narrative writing, unblinding procedures, and DSMB/IEC communications—ensuring the integrity and safety of your investigational products.