Regulatory Labelling Management

A product label is very specific and precise in its content, especially with respect to safety data and adverse effects and RegOrbit offers following labelling management services

Structured Product Labeling (SPL) 

  • US FDA SPL conversion services and support all types of products including prescription drugs, Over the Counter (OTC) products, veterinary medicine, homeopathic products, and bulk ingredients
  • Support to dispatch and publish SPL in the DailyMed
  • Support establishment registration & NDC labeler code requests for all categories of drugs

Labeling Navigation System Development 

  • Support to define a standard & harmonised way of managing and filing all Labelling documents
  • Develop a central location to access Current, Registered Labelling documents (SmPC, PIL and USPI)
  • Establish a solution that allows the current Labelling documents for individual products and markets more easily accessible across all business functions

Structured Product Monograph (SPM)

  • Preparation of Health Canada SPM in the XML Format
  • Managing, recognizing, and resolving the errors made while publishing SPM in XML format
  • Conversions of both French and English formats for SPM
  • Technical validation

Structured Electronic Product Information (ePI) 

  • The electronic product information (ePI) initiative is launched to support the digital transformation of healthcare across the Europe
  • A free ePI tool will be offered by the EU regulators, this free tool can be used by the marketing authorization holders to create their ePI for submission in an application
  • We offer expertise to review EU ePI requirements and support to implement the ePI process in your organization