COMPANY
Pharmacovigilance & Compliance services.
https://www.aegisana.com
https://www.aegisana.com
DESCRIPTION
Aegisana is at the forefront of the evolution of life sciences services with efficient and effective Pharmacovigilance and Auditing solutions. We create value and confidence for our customers through a combination of technical expertise, applied useful technology and outstanding customer experience. Our extensive Clinical Safety and Pharmacovigilance services also encompass Veterinary and Cosmetics to provide a wide offering and continuity of provision for clients with products across these areas. We have a comprehensive Auditing and Quality Assurance service that covers GCP, GVP, VGVP, GMP and GDP consultancy solutions, and can also offer practical support from inspection readiness through to audits and inspections, remotely or on-site. Headquartered in Madrid, we also have technical centres in Barcelona and Lisbon and we’re expanding rapidly in other locations across Europe. Our wide partner network allows us to undertake client projects spanning multiple countries and authorities across Europe and beyond.
SERVICES
01/06
Clinical Safety
•Responsible Person Services
•Clinical Trial Documentation
•Safety Management Plan
•SAE & SUSAR Management
Pharmacovigilance
•EU-QPPV services
•Eudravigilance Management
•SPOR
•Article 57
•ICSR/AER Management
•Global Literature Monitoring
•Safety writing & Aggregate reports
•PSMF Management
•Signal Management
•Regulatory Intelligence
•Safety Communications
•Benefit-risk, RMPs & REMS
•Local Literature Monitoring
•LPPV & Local Safety Personnel
•Local Case Management
•Drug Safety Physician
•SOP Creation & Review
•Pharmacovigilance training
Veterinary Vigilance
•EU-QPPV services
•EVVet Management
•SPOR
•Union Product Database
•Adverse Event Reporting
•Global Literature Monitoring
•Safety writing & Aggregate reports
•PSMF Management
•Signal Management
•Regulatory Intelligence
•Safety Communications
•Benefit-risk, RMPs & REMS
•Local Literature Monitoring
•Local Safety Officer
•Local Case Management
•Regional Representative
•SOP Creation & Review
•Veterinary Pharmacovigilance training
Cosmetovigilance
•Cosmetic AER Management
•Responsible Person
•Global Literature Monitoring
•Local Literature Monitoring
•Regulatory Intelligence
•SOP Creation & Review
•Cosmetovigilance training
GCP
•GCP Auditing & Inspections
•SOP Creation & Review
•Gap Analysis
GVP/VGVP
•GVP Auditing & Inspections
•Audit Program Management
•Deviation & CAPA Management
•Gap Analysis
•SOP Creation & Review
•SDEA & PVA Management
•Vendor Management
•Remote & Desktop Auditing
•GVP/ VGVP Training
GMP
•GMP Auditing & Inspections
•Audit Program Management
•Deviation & CAPA Management
•Gap Analysis
•SOP Creation & Review
•Supplier Qualification
•Change Control
•Process Validation Review
•Qualified & Responsible Persons
•BMR/BPR Creation & Review
•Manufacturing Transfer
•Product Quality Review
•Quality & Technical Agreements
•GMP Training
GDP
•GDP Auditing & Inspections
•Audit Program Management
•Deviation & CAPA Management
•Gap Analysis
•SOP Creation & Review
•Supplier Qualification
•Change Control
•Qualified & Responsible Persons
•Remote & Desktop Auditing
•GDP Training