Services

Services

• Pharmacovigilance
• Cosmetovigilance
• Materiovigilance
• Veterinary Pharmacovigilance
• Geriatric Pharmacovigilance
• Med Communications
• Regulatory Affairs
• Clinical Operations
• Medical Writing
• Audits and Compliance
• Quality Assurance
• Maintenance of QMS
• Supporting Promotional Materials
• Training
• Market Access
• Clinical Safety
• Responsible Person
• Medical Review
• Fachtechnisch verantwortliche Person (FvP)
• And, much more!

Clinical Services:

Clinical Safety, Clinical Operations, EDC, Site Support, Data Management, Biostatistics, Medical Writing, Data Safety Monitoring Board, & Clinical Evaluation Committee(CEC’s)

Drug Safety:

Clinical Safety, Case Management, Global/ Local Literature Search, Medical Reviews, Aggregate Safety Report Authoring, EU & UK QPPV, Signal Evaluation & Risk Management, Submissions, PV Operation Services, PV Quality, Audits, Inspection Readiness & Compliance Management, Safety Data Exchange Agreements (SDEA’s) & Pharmacovigilance Agreements (PVAs) Authoring.