Publishing and eCTD services – tackling global submission challenges

Life sciences companies face a host of operational challenges with managing global submissions. These include meeting complex timelines, fluctuation in submission volume throughout the year, variations in requirements from region to region, and the complexity of gathering data from different functions and from affiliates. In addition, companies must deal with the logistical challenges of managing IT tools and systems, many of which don’t provide an end-to-end view of the submission process.

Celegence – a global perspective to submission publishing

Celegence provides dossier submission services worldwide, supporting both eCTD and Non-eCTD electronic submissions [NeeS] formats. All submission services are supported by our experienced regulatory intelligence team, whose deep knowledge of local and regional guidelines ensures the provision of compliant and efficient regulatory publishing services.

Our eCTD publishing services and document level publishing expertise take the complexity out of commonly experienced problems, such as formatting and hyperlinking issues, floating sections, and error corrections.

Celegence’s dedicated offerings support:

  • Dossier submission services to multiple health authorities
  • Paper to NeeS to eCTD conversions in keeping with health authority formats worldwide
  • Regulatory intelligence services to deliver support and interpret 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 WRITING

Medical writing – delivering specialty knowledge

MEDICAL DEVICES

Medical devices – addressing a changing regulatory environment

REGULATORY LABELING

Regulatory labelling – supporting client requirements from creation to maintenance of global and local drug product labelling

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

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