- Classification
- What the product is decides how it is filed. Medicine, medical device, food
supplement, health product or cosmetic — the classification sets the pathway, the
evidence required and the timeline.
- Registration strategy
- Which pathway, in which order, with which supporting certificates — and what to
file first when a range is entering the market together.
- Realistic timelines
- Dates given in writing at the start, and revised in writing when the authority
moves. We would rather give you a date you can plan against than one you would prefer
to hear.
- CTD & eCTD
- Guidance on assembling and submitting the dossier in the structure and format the
SFDA expects, so the file is not returned for its shape before it is read for its
content.
- Dossier localisation
- A dossier written for another market adapted to the requirements of this one —
gaps identified early and requested from the manufacturer once, not four times.