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Services

Development Consulting

► Regulatory and scientific consultancy services
► Integrated product development and project management
► Regulatory strategy (incl. health agency interactions), gap analysis and due diligence
► Scientific, regulatory and medical writing
► Development CMC, consulting and manufacturing strategy
► Statistical services across nonclinical and clinical development
► Health economics / market access / pricing / strategic advice
► Labeling services
► Medical affairs & marketing strategy

Regulatory Affairs

► Initial marketing authorization applications, line extensions and referrals in > 80 countries worldwide
► Full portfolio maintenance service (e.g. variations, renewals) across all regions
► Global roll-out strategy for new submissions including due diligence activities
► Consultancy and regulatory operations during M&A activities
► Change control procedures/ CMC writing for chemicals and biologicals
► Electronic submission services in all formats
► CCDS development & worldwide roll-out
► Procedure management and health agency contacts

Pharmacovigilance

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

Quality Management & Compliance

► Develop phase appropriate quality system
► Gap analysis, remediation and implementation
► Pre-approval inspection readiness (Mock PAI audit)
► Warning letter and consent decree remediation
► External and internal audits
► Routine compliance support (Document control, CAPA, batch release)
► EDMS and CSV (21 CFR part 11 compliance)
► Microbiology and analytical quality control Support