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Regulatory Writing


  • Common Technical Documents
  • Clinical and non-clinical overviews
  • Summary of product characteristics
  • Pack Insert and Labels
  • Clinical expert statements
  • Briefing documents
  • NDAs/ANDA/IND
  • Company Core Safety Information (CCSI), Company Core Data Sheet (CCDS)
  • Summary of Product Characteristics (SmPC)
  • Literature and Brochure for medical devices