Regulatory Operations

Overview

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

Our Services

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.