Company Overview
We are Pharmacovigilance service provider for the Latin America region with operations in 24 countries in South America, Central America & Caribbean and Mexico. Our efforts are focused on patient’s safety. We offer high quality services in Pharmacovigilance with local presence, regional experience and global knowledge. We are a team of physicians, pharmacists, biochemists, and biologists with extensive experience as medical advisors, safety managers and regulatory affairs specialists in pharmaceutical companies and first level CROs.
We have developed a complete pharmacovigilance service, with modules adapted to each client needs, and in compliance with the regulatory requirements of each country.
Transparency in management and communication is one of our commitments
Company mision: to provide excellent services and grant our clients quality support in their pharmacovigilance actions, throughout the life cycle of the product.
Company vision: to become a company respected for its quality by colleagues, employees, customers, patients, and regulatory authorities throughout the region.
Company Values: Commitment to patient safety. Quality of services. Confidentiality
Company services:
Local Qualified Person for Pharmacovigilance in 24 countries.
Pharmacovigilance Intelligence for all LATAM region
Local Literature Screening
Individual Case Safety Management (Adverse Events)
Pharmacovigilance for Orphan Drugs.
Audits (with native local language speaking auditors)
Preparation for inspections (focused on local requirements).
PV in Compasionate use programms
PV for Name Patient Use
Pharmacovigilance Unit start up
Writing and adapting of Standardized Operating Procedures (SOPs)
In-company trainings and training programs
Medical Information
Preparation of Risk Management Plans (RMPs), including follow-up of local actions
Intensive Pharmacovigilance Programs
Writing and/or adapting to local regulations all Periodic Reports (PSURs/PBRERs, CRP, DSURs)
After-hours and out of office support (24/7)
Pharmacovigilance agreements
Updating of leaflets and information for the patient
Design and management of Phase IV studies and post-authorization safety studies (PASS)