Pharmacovigilance and technovigilance, ready for the 2027 standard.
A system built for ICH E2B(R3) from day one. Native automation, regional coverage under a single contract.
ARCSA activates E-Reporting in August 2027.
Ecuador, Peru, Colombia, and the rest of Latin America's regulatory authorities are migrating to the ICH E2B(R3) standard for electronic adverse event reporting. Manufacturers with regional presence need a pharmacovigilance system that not only complies today, but is prepared for the next enforcement cycle.
AI + automation native, not layers on top of legacy systems.
Our pharmacovigilance system enters operation January 2027 — nine months ahead of ARCSA's deadline. It was built AI-native from design: case processing with assisted classification, automated regional literature monitoring, quarterly ICSR reconciliation with cross-validation, and E2B(R3) reporting without intermediate transformation layers.
One contract, eight markets, one interlocutor.
Local QPPV in each market, 24/7 contact with regulatory authorities, case management under the same regional methodology. We consolidate your Latin American pharmacovigilance obligation without fragmenting it into eight separate contracts with eight local providers. European regulatory consultancies already rely on us for pharmacovigilance execution in the region.
What the service includes
Project setup
- Local pharmacovigilance contact point
- Kick-off meetings with client team
- Training on client procedures and products
Routine services
- 24/7 contact with regulatory authorities
- Regional literature and website monitoring
- Quarterly ICSR reconciliation
- Quarterly QPPV oversight meetings
- Annual pharmacovigilance training
Talk to our pharmacovigilance team about your portfolio and target markets. We respond within the next 48 to 72 hours.
Talk to the pharmacovigilance team