We provide publishing services at all stages of product development from formatting of regulatory documents, submission via electronic Gateways, through compilation of the entire eCTD dossier. eCTD is the specifically formatted and structured electronic standard for medicinal product dossiers throughout many regions including the US, Europe, Canada, Australia, Japan, China amongst others. eCTD has become the mandatory submission format for MAA, IND, NDA, BLA, ANDA; DMF and more.With almost 1,000 submissions annually, we have extensive experience in compilation, maintenance, and life-cycle management of eCTD submissions.
We compile and submit your entire application your eCTD dossier according to the latest regional specifications in the EU, US, UK, Switzerland, Canada, and other regions.
We support you with:
- Advice on eCTD structure and required documentation
- Document format and publishing
- Assessment for e-submission readiness
- eCTD application creation including:
- SPL
- Datasets (SEND, ADaM, SDTM, legacy)
- CSR
- STF
- CRF
- Hyperlinking
- Validation
- Submission to the Agencies
- eCTD Lifecyle Management
