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The PharmaLex Group combines local expertise with global reach in the area of Development Consulting & Scientific Affairs, Regulatory Affairs and Pharmacovigilance. 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.


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


► 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

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.


Offices in 13 Countries