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Services

Development Consulting &
Scientific Affairs

► Development strategy and gap analysis
► Clinical trial designs
► Health authority briefing documents
► Scientific advice and health authority meetings
► Due diligences
► CTD clinical & nonclinical documents
► PIP / PIP waiver, pediatric study plans
► Environmental risk assessment

Regulatory Affairs

► Procedure management / health authority contact
► Electronic submission services in all formats
► Change control procedures / CMC writing
► CCDS development and worldwide roll-out
► Full maintenance service
► Initial marketing authorization application,
► Line extensions and referrals

Pharmacovigilance

► Risk management
► Signal management
► Periodic safety reports
► Pharmacovigilance system and compliance
► EU-QPPV / local QPPV
► Quality system, audit and inspection support
► Safety data exchange agreements
► ICSR management, including collection, evaluation, processing, distribution and reporting