Our experienced team of therapeutically aligned medical writers support your product development by optimizing your presentation of clinical information with a wide variety of medical and scientific documentation. Our flexible services are available as part of your comprehensive program or as stand-alone assignments.

Avania’s expert medical writing team compiles, organizes, writes, edits, and produces documentation for:

  • Extensive expertise to help you plan an optimal study design
  • Direct market feedback through meetings with panels of clinical experts
  • Access to the key opinion leaders and surgical experts throughout the U.S. and Europe
  • Postmarket surveillance (PMS) plan and/or a postmarket clinical follow-up (PMCF) plan in line with FDA, TGA, and Medical Device Regulation (MDR) requirements
  • Annual reports
  • Accurate, timely clinical evaluation plans and reports (CERs)
  • Medical writers with in-depth knowledge about standards in the U.S. (21 CFR), Europe (ICH E6), and Australia (ISO 14155)
  • Expert guidance regardless of if studies were performed in both the U.S. and EU or if data is submitted to the FDA, TGA, and a notified body
  • Pre-regulatory meeting briefing documents
  • Preclinical study reports, expert reports, and summaries
  • Benefit-risk assessment reports
  • Patient narratives
  • Highly skilled, systematic medical and scientific literature reviews for any topic
  • Abstract, manuscript, and journal article creation
  • Extensive experience in premarket clinical trials to guide your investigator’s brochure and ensure alignment with regulatory standards

Your product is important, and it takes a team with specialized medical writing expertise to move it forward. It Takes Avania.

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