Services
and capabilities

eCTD Regulatory Submissions

Our team is well-versed with the ICH Common Technical Document (CTD) specifications for marketing authorization in all therapeutic areas and indications. We prepare, publish and compile eCTD submissions per the following:

  • Abbreviated new drug applications (ANDA)
  • Biologics license applications (BLA)
  • Clinical trial authorization/application/exemptions (CTA/CTX)
  • Clinical trial notifications (CTN)
  • Drug master files (DMF)
  • Fast track applications
  • Investigational device exemptions (IDE)
  • Investigational new drug applications (IND)
  • Investigational Medicinal Product Dossier application (IMPD)
  • Marketing authorization applications (MAA)
  • New drug applications (NDA)
  • New drug submissions (NDS)
  • Orphan drug applications (ODA)
  • Life Cycle Management and maintenance

 

Per the above submissions, we provide a complete service offering, tailored to your needs –

  • Version Management & Control
  • Template Management
  • Report writing and dossier preparation
  • Standardization of documents according to the CTD specifications
  • Legacy documentation conversion – scanning, redrafting, standardizing
  • Bookmarking & hyperlink management
  • Pagination & volumisation
  • CTD and eCTD conversions from other formats
  • Regulatory lifecycle management
  • Document amendments & resubmission

Utilizing industry-leading automated eCTD validation tools to verify that submissions meet the technical requirements defined by the ICH, regional-specific requirements and industry best practices