PHARMA SAFE LATAM

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.

Pharmacovigilance

Integrated medicine safety operations, local contact points and regulatory compliance support.

  • ICSR Individual Case Safety Report.
  • PSUR/PBRER Periodic safety reporting for regulated products.
  • Risk management plans
  • Safety signals
  • Scientific literature
  • SOPs Standard Operating Procedures for regulated processes.
  • CAPAs Corrective and Preventive Actions.
  • Third-party oversight

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 Health Technology Assessment.
  • RWE Real World Evidence.
  • 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 Quality Management System.
  • SOPs Standard Operating Procedures for regulated processes.
  • CAPA Corrective and Preventive Action.
  • KPIs Key Performance Indicators.
  • Internal audits
  • Compliance

Audits and Inspections

Document readiness, mock inspections and technical support during health authority inspections.

  • Mock inspections
  • Gap assessments
  • CAPAs Corrective and Preventive Actions.
  • COFEPRIS Mexican health authority.
  • FDA United States regulatory authority.
  • EMA European Union medicines regulatory agency.
  • ANVISA Brazilian health authority.
  • INVIMA Colombian health authority.

Environmental Sustainability

ESG and environmental management services for life sciences, pharmaceutical and food companies.

  • ESG Environmental, Social and Governance.
  • Circular economy
  • Environmental management
  • Indicators
  • Reports

Training

Courses and workshops for pharmacovigilance, technovigilance, quality and regulatory teams.

  • GVP Good Pharmacovigilance Practices.
  • GCP Good Clinical Practice.
  • GDP Good Distribution Practices.
  • ICH International Council for Harmonisation.
  • Workshops

Clinical Trial Support

Technical support for safety operations, pharmacovigilance agreements and participant protection.

  • Safety management
  • Medical monitoring
  • Pharmacovigilance agreements
  • Participant protection