Pharmacovigilance
Integrated medicine safety operations, local contact points and regulatory compliance support.
- ICSR
- PSUR/PBRER
- Risk management plans
- Safety signals
- Scientific literature
- SOPs
- CAPAs
- Third-party oversight
Patient Safety • Regulatory Excellence • LATAM Solutions
Specialized pharmaceutical consulting for Latin America.
PHARMA SAFE LATAM supports regulated organizations in safety surveillance, compliance, scientific evidence and risk management.
A boutique approach for pharmaceutical companies, biotechnology organizations, CROs, medical device manufacturers and health institutions.
Patient safety Regulatory compliance Evidence and value Latin American reach Sustainability and ethics
Vigilancia y Consultoría Farmacéutica
Science, compliance and patient safety.
The proposal defines a regional firm focused on surveillance outsourcing, strategic consulting and high-specialty pharmaceutical services for Latin America.
ICHGVPGCPFDAEMACOFEPRISNOM-220NOM-240ANVISAINVIMADIGEMIDISOHEORRWEHTA
Services
Services
The portfolio is based on the original web proposal and identifies capabilities that can be deployed in stages according to country, product and regulatory need.
Technovigilance
Post-market surveillance, incident investigation and regulatory support for medical devices.
- Adverse incidents
- Regulatory reports
- Document control
- Risk-benefit analysis
- Inspection support
HEOR and Pharmacoeconomics
Economic analysis and evidence generation for clinical, economic and market access decisions.
- Cost-effectiveness
- Cost-utility
- Budget impact
- HTA
- RWE
- Value dossiers
- Markov models
Regulatory Affairs
Strategic support for health registrations and technical documentation for health products.
- Marketing authorizations
- Renewals
- Variations
- Technical dossiers
- Regulatory strategy
Quality Management
Design, review and implementation of quality systems for regulated operations.
- QMS
- SOPs
- CAPA
- KPIs
- Internal audits
- Compliance
Audits and Inspections
Document readiness, mock inspections and technical support during health authority inspections.
- Mock inspections
- Gap assessments
- CAPAs
- COFEPRIS
- FDA
- EMA
- ANVISA
- INVIMA
LATAM Coverage
LATAM Coverage
Coverage is presented as target markets and regional service reach, adapted to each country's regulatory context.
México Costa Rica Colombia Perú Brasil
MéxicoCosta RicaPanamáEl SalvadorBrasilColombiaPerúChileArgentinaRepública DominicanaGuatemalaEcuadorUruguayParaguayBolivia
PS LATAM