One of our experienced medical writing experts will work with you in the production of single or multiple documents to support regulatory submissions. Examples include:
- Briefing documents in support of scientific advice/agency meetings
- eCTD materials for marketing authorisation applications or variations/amendments
- Clinical trial application (CTA)/investigational new drug (NDA) documentation
- Safety update reports
- Annual reports
The medical writing will be carried out in line with your agreed brief, with a timeline and deliverables agreed upon upfront as part of the process.
1 Medical Writing Unit equates to 8 hours of medical writing expertise. This includes the time for all aspects of the writing procedure, including planning, meetings, research, writing and editing upon review/comments. You can select multiple units dependent upon your individual project requirements.
If you are unsure about your exact project needs please contact us before purchasing any units. Any complete unused units can be refunded. Any partially remaining units will be held as credit on your account.