Azierta Services | Specialized pharma & health consultancy

TOXICOLOGY

• Toxicological Evaluation of Impurities
• Elemental Impurities: ICH Q3D
• OEL & Categorisation of APIs
• ERA Reports
• PDE/ADE Reports

REGULATORY AFFAIRS

• Regulatory Strategy
  
• Post-Authorisation Maintenance
  
• Medical Devices
  
• Registration Dossiers Audits
  
• Regulatory Counselling during Clinical Development
  

PHARMACOVIGILANCE AND SAFETY

• Vigilazierta: Technological Solution for PV
  
• Safety Reports: PSURs, DSURs, ACO, RMP
  
• Pharmacovigilance in Clinical Trials
  
• Post-Marketing Pharmacovigilance
  
• Medical Devices Vigilance
  
• Audits and GVPs
  

MEDICAL DEVICES

• Export to the USA (FDA)
  
• Post-Marketing Surveillance
  
• Market Access Strategy
  
• Industrial Property and Patents
  
• Quality Systems (EN ISO 13485)
  
• Regulatory Consultancy (CE Marking)
  

MEDICAL AFFAIRS

• Medical Information Premium
  
• Clinical Research and Development
  
• Medical-Marketing Strategies
  
• Market Analysis
  

QUALITY SYSTEMS

• GDPs Implementation
• GMP Support
• Quality Systems Implementation
• GMP Compliance Adviser
  

HEALTH

• Strategy solutions and business development
  
• Health administration and management
  
• Health infrastructures support
  
• Specialized training
  

OTHER SERVICES

• Due Diligence
• Global Scientific Support