Global Publishing Services and eCTD Conversion

Life sciences companies face the challenge of understanding regulatory agency submission requirements, fluctuations in submission requirements, gathering information from various contributors, and more. On top of these operational challenges, managing the IT systems and tools that may or may not present the end-to-end process of a submission can also create roadblocks.

Celegence supports dossier submissions worldwide, for both eCTD and Non eCTD electronic submissions [NeeS] formats. Our in-house Regulatory Intelligence team has comprehensive knowledge of local and regional guidelines, ensuring that your submissions will be both compliant and efficient.

Celegence can help your business with the following dedicated niche offerings:

  • Support dossier submissions to multiple health authorities
  • Paper to NeeS to eCTD conversions for various global HA formats
  • Regulatory Intelligence repository built for understanding regional and national requirements
  • Regular quality check and adherence to predefined SLAs
  • Extension of your publishing team and management of your submission tool with business-process-as-a-service model

 

Learn more about our niche service offerings:

MEDICAL DEVICES

Global Expertise for Medical Devices

REGULATORY LABELING

Maintenance of Labeling Information, including Safety and Efficacy information

REGULATORY OPERATIONS MANAGEMENT

Managed regulatory operations related to publishing, submission and regulatory information management for reduced total cost of ownership

IDMP & COMPLIANCE CONSULTING

Organizational readiness assessment for IDMP, xEVMPD and UDI compliance and support activities like data collection, maintenance, submission and governance

REGULATORY INTELLIGENCE SERVICES

Proactive monitoring of regulation changes to assess the impact to your product portfolio

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