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
PHARMA SAFE LATAM
Services
Initial portfolio of high-specialty pharmaceutical services for surveillance, regulation, quality, evidence and sustainability.
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
Environmental Sustainability
ESG and environmental management services for life sciences, pharmaceutical and food companies.
- ESG
- Circular economy
- Environmental management
- Indicators
- Reports
Training
Courses and workshops for pharmacovigilance, technovigilance, quality and regulatory teams.
- GVP
- GCP
- GDP
- ICH
- Workshops
Clinical Trial Support
Technical support for safety operations, pharmacovigilance agreements and participant protection.
- Safety management
- Medical monitoring
- Pharmacovigilance agreements
- Participant protection