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Dedicated. Experienced. Flexible. PharmaLex combines local expertise with global reach in the area of Development Consulting, Regulatory AffairsPharmacovigilance as well as Quality Management & Compliance. We have extensive experience in all therapeutic areas and product groups including advanced therapy medicinal products and biopharmaceuticals, medical and borderline products and alternative therapeutic approaches. We have a proven track record of success in outsourcing programs with more than 30,000 successfully completed projects for over 600 clients worldwide.

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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

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

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

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



Our vast network allows us to help customers to go beyond regulatory compliance. We enable them to capitalise on greater efficiencies, simplify the regulatory process and deliver business value and growth. Our priority is to provide flexible and approachable services that can be tailored to the needs of the client and consistently deliver successful outcomes and exceed expectations.

25

Offices in 14 Countries

40

Nationalities

650

Employees