We expedite the entire regulatory submissions management process, from dossier development, submission planning, tracking, publishing to final submissions.
- Global eCTD Publishing and Submission Services
- Non-eCTD Electronic Submission (NeeS)
- Paper Submissions
- Legacy Conversions
- Clinical Study Report (CSR) – Report Level Publishing
- Structured Product Labeling (SPL)
- Regulated Product Submissions (RPS)
- Drug Master File (DMF) Submissions
- Submission Dispatch Management including electronic gateways, CDs and Prints
- Product dossier and document management
Other activities supported by CONTINUUM under Regulatory Operations include:
- Regulatory Compliance Audit Programs
- Regulatory database clean-up & maintenance
Dedicated Customer Teams & Agile Services
Our strong team of experts ensures the professionalism, expertize, timeliness & cost efficiency required to ensure that your plans are carried out as needed.