Medical Writing Services

Medical writing is an essential part of the healthcare industry, as it enables medical professionals to communicate their findings and research in a clear, concise manner. It also allows for accurate documentation of patient information and treatments, which helps ensure that patients receive the best possible care. Medical writing also helps to bridge gaps between different disciplines within medicine by providing a common language for all involved parties. Furthermore, medical writing ensures compliance with regulations set forth by governing bodies such as Health Canada or FDA (Food & Drug Administration). Ultimately, professional medical writers help facilitate better communication between health professionals and provide quality assurance when it comes to patient safety and care. SZReg Pharma Medical Writing Expertise include:

  • Non- Clinical overviews (eCTD Module 2.4) and Non-clinical summaries (eCTD Module 2.6)

  • Clinical overviews (eCTD Module 2.5) and Clinical Summaries (eCTD Module 2.7)

  • Compilation of eCTD Module 4 & Module 5

  • SPC, PIL, PADER, RMP

  • Clinical Study protocol, Clinical Trial reports & Investigator’s brochure

  • Biowaiver justification support

  • Query responses for documents of CA., EU, UK, GCC, and emerging regulatory markets

  • Annual reports for safety & clinicals