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- Compilation of registration dossier based on the data and results of the client
- Evaluation of available documentation and production of deficiency lists
- Carrying out the full registration process of a medicinal product
- Medical writing:
- Expert overviews and summaries (CTD Module 2.4, Module 2.5, Module 2.6, Module 2.7)
- Preparation, translation and updating of SmPC, PIL and Label texts
- Translations
- eCTD/NeeS compilation and publishing
- Application to authorities (national, MRP and decentralized procedures)
- To be local contact at relevant HU Agencies, handle local e-Submissions (via mandatory local e-Portal, called „Cégkapu”) and receive decisions via local e-Portal, forward them to the client. Local HU contact is mandatory in local regulatory processes.
- Coordination and follow-up during the registration process
- Continuous contact with the respective authorities, organisation of meetings
- Life-cycle management including:
- Variations, renewals
- Other modifications
- Readability Test (User Testing – testing volunteers, compiling User Test Report in English)
- Writing Bridging Reports
- Mock-ups: proof-reading/handling Patient Information and Label artworks (including Braille certificate)
- Representing companies in national/MRP/DCP processes
- Helping clients to finalize national phase of Central Registrations and submit/handle subcategory classification process to start marketing with the adequate prescription status
- local Pharmacovigilance service (local contact person) and help clients in Pharmacovigilance questions and other tasks
- compilation of educational/risk minimisation materials, coordination
of approval/notification process, advice on distribution of risk
minimisation materials
- medical checking of promotional materials, medical advice service
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