91黑料

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Regulatory Operations

91黑料 provides a full range of regulatory submission publishing services, including document formatting, submission readiness, report-level publishing, eCTD/NeeS/paper publishing, quality control, dispatch and archival submissions. 

Our success has been demonstrated by compliant dossiers worldwide.

Our Regulatory Operations teams also offers technology and information management services. We have direct experience implementing, maintaining and working with client-owned and industry-standard electronic regulatory systems including Veeva, DocuBridge etc. The team supports clients with centralised data entry and information governance services.

Key services

 

Strategic consulting and operational execution of core services and/ or across service lines:   

  • Standalone submission-ready quality control and formatting

End-to-end publishing of all global submission types and formats:

  • Operational publishing activities, e.g. Clinical Trails Information System, including low-cost country expansion
  • CTIS submissions 

Regulatory technology and end user support: 

  • Own, maintain, administer and support internal and client systems
  • Technology and submission/IM process consulting
  • Automation initiatives

Regulatory information management: 

  • Tracking, maintaining and reporting regulatory data
  • Regulatory Information management support of readiness for new and evolving regulatory requirements, e.g. Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) / Post Market Surveillance, etc.
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