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Latika Rana-Afi is a regulatory medical writer offering services for clinical trials, biotech and pharmaceutical teams. The work involves authoring and editing core regulatory documents such as clinical study protocols, investigator's brochures, clinical study reports, and eCTD and CTD module content. Documents are prepared to ICH, ICH-GCP, MHRA, FDA and ISO standards and include editing, quality control, version control and compliance review. The service also covers eCTD submission support, coordination of review cycles, and drafting responses to regulatory questions. Additional support includes structured literature reviews and data summarisation to underpin regulatory narratives. The writer is UK-based, works remotely, and states she is open to new projects.
- Website
- latikarana-afi.com
- Phone
- +447526773538
- Categories
- Pharmaceuticals, Biotechnology, Information services