Provider of Premier Documents

This is Illyria... provider of premier documents to the biopharmaceutical industry. Illyria creates documents that stand alone or fit directly into your electronic Common Technical Document (eCTD)-compliant drug applications (eg, IND, CTX, CTM, NDA, BLA, MAA).

Illyria also supports your organization’s infrastructure by producing ICH-compliant templates, SOPs, and work practice guidelines, and by managing and developing medical writing groups.

Illyria's expertise includes:

  • Study reports, study protocols and amendments, registry protocols, investigator brochures, patient safety narratives
  • CTD Module 2 summaries, ISSs, ISEs
  • Pre-meeting packages, orphan drug applications, data safety monitoring board (DSMB) charters, informed consent forms
  • Journal articles, white papers, text for scientific posters, SOPs, corporate communication policies
  • Safety documents: DSURs, PSURs, PBRERs