Meny
For us, being in the pharma regulatory world, medical writing includes scientific writing, regulatory writing and eCTD writing.
Our Medical Writers combines knowledge in writing and science to produce fit for submission documents in compliance with current guidelines, templates, and standards.
The RegFile team will support you in the
writing of high quality documents such as:
– Briefing document for competent authority interactions
– Investigator’s Brochure (IB) &
Investigational Medicinal Product Dossier (IMPD)
– Non-clinical and clinical overview and summary for eCTD
– Risk Management Plan (RMP)
– Paediatric Plan (PIP)
– Development Safety Update Report (DSUR) &
Periodic Safety Update Report (PSUR)