Literature-Based Medicine Submissions
Many experienced pharmaceutical regulatory professionals understand the challenges in utilising published literature as their key supporting documentation for TGA submissions. However, these bibliographic submissions can represent significant opportunities to open new patient groups, register new formulations, add key text to Product Information, and even bring older medicines onto the Australian market for the first time.
Brandwood CKC has extensive experience in the development and submission of bibliographic applications with a comprehensive service encompassing:
- development of the initial search strategies
- suitable engagement with the regulatory agencies
- reviewing and classifying literature search results
- assembly of the application
- development of overview/summary documents.
Through our extensive network amongst the medical and scientific community, we can also assist in identifying and engaging clinical and technical experts to support the applications.