Our eCTD service to create or revise registration dossiers includes: - Creation and submission of eCTD sequences using our installed eCTD software (Extedo)
- Creation of an eCTD baseline (reflecting the current data status of your dossier)
- Consideration of regional requirements (EMA, CMDh and national authorities) and corresponding validation criteria
- Reformatting of your volume of approved applications e.g. from NeeS to eCTD
- Conversion of old-NTA dossiers to eCTD
- Creation of eCTD sequences from existing DMFs / ASMFs
Additional services to support you: - Dossier updates (Quality Overall Summary, Non-Clinical Overview / Summary, Clinical Overview / Summary) in collaboration with the client
- Variation management and eSubmissions (CESP, eSubmission Gateway, etc.)
- Translation by our translation and language management into all desired target languages
orangeglobal group has more than 10 years of project experience in dossier management and eCTD creation. |