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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)
    • 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
    • Pharmacovigilance – outsourcing to an external company, but we can help clients in many Pharmacovigilance questions
      • others tasks

 



Pro-Pharma ’93 Gyógyszeripari Tanácsadó Intézet Kft.
1144 Budapest, Füredi utca 34.
Tel.: 06-1-231-8060 Fax: 06-1-790-1038
e-mail: company@propharma.hu