Global Regulatory Registration Services Our services • Regulatory advice on development and interactions with regulatory agencies • Clinical Trial Application (CTA) • Scientific Advice (EMA or national agencies) • Orphan Drug Designation (ODD) • Paediatric Investigation Plan (PIP) • Drug registration and registration strategy • MAA dossier preparation: Data analyses, strategic input and scientific writing of all CTD sections • Management of post approval commitments The team • Post MAA regulatory maintenance: CMC, clinical & safety Variations A team of highly qualified consultants with • Regulatory publishing (eCTD, NeeS) significant hands-on industry experience • CMC compliance projects including experts in Regulatory Affairs, CMC • Platforms: Development of Specific (client or activities) supports and publishing. platforms Our clients When work with us? From start-ups to global pharma companies The team covers the whole development process as a consultant or with punctual, repetitive or permanent need operational support, from concept to approval, on a global or multi- for support. national projects. Among our latest missions Why work with us? • Full integration of our consultants within global project teams for Our team hold a flexible skill set ranging development projects (new indications, line extensions) from development strategy to operational • Management of Centralised Procedure execution, as well as leading and managing projects. • Provision of all module 1 documents including development of SmPC, They can provide expert advice followed by risk management plan, environmental risk assessment hands-on operational activities.