The Medical Writing services cater to the regulatory aspect by searching literature / Published studies / Journal Articles Or buying individual published articles from different sources.
- Justification for fixed dose combination.
- Prepare Periodic Safety Update report (PSUR).
- Prepare Summary of product (SPC), Pack Insert, Product rationale.
- Expert Reports on - Quality, Pre-clinical, Clinical
- Overviews - Clinical / Non-Clinical (Module 2)
- Nonclinical Study Reports (Module 4)
- Clinical Study Reports (Module 5)