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MedLexicon is a company based in Russia, Moscow, specializing in the development and review of localized country-specific regulatory packages on all phases of clinical drug development.

This includes:
  • preparing files submitted to regulatory authorities in support of a request to authorize a biomedical study in humans (or animals)
  • developing national master or site-specific versions of documentation given to study subjects
  • validation of tools used to quantify Patient Reported Outcomes and Quality of Life measures
  • maintaining Investigators' Site Files and Trial Master Files and providing standardized documents required before, during and after the study,
  • developing study-specific forms, depending on the specific study design and objectives,
  • help in audits (independent review), site visits, Investigators' meetings, Q&A logs
  • medical writing of clinical study protocols, Investigator's Brochures, safety summaries or case narratives/listings
  • processing all kinds of safety reports (from initial SAE narratives on a site-level to CIOMS/MedWatch notifications) on an expedited basis
  • transforming raw and scattered technical data into summaries of manufacturing process of formulation compliance testing
  • involvement at the most important stages of a compound registration dossier in pursue of a marketing authorization
  • verification, reviewing and updating pre-existing documents
  • recommendation on any outstanding deficiencies and implementation of corrective action to bring a regulatory approval forward
...and many more related functions.

Additionally, we perform oral medical translations.

The company is operating on Russian, Ukrainian, Belarusian and Lithuanian markets.

Contact us at info@medlexicon.net