Regulatory Operation Strategic Consulting

Our Regulatory Operation Strategy expert team have the deep capabilities required to complement to design and implement regulatory operation business model and processes and we deliver strategies to support the successful change management processes.

  • Regulatory Operation organization design (Big, small and mid-sized pharma companies)
  • Build regulatory operation business model to support highest effectiveness and efficiency with no compromise to the quality
  • Insourcing and outsourcing model with increased success and cost saving options and support outsourcing vendor selection fit for your business needs
  • Support systematic and objective design process that ensures to create powerful teams

User Trainings

Global regulatory agencies are implemented mandatory use of eCTD standards hence regulatory professionals must stay up to date with the latest regulations and trends. RegOrbit offers individual and group end to end eCTD trainings (Author> compilation> Review> Dispatch> Archive) based on your organization needs upon completion of our trainings, you will understand how to organise eCTD applications in the correct format, how to navigate and review the eCTD dossier and also examine life cycle eCTD management to ensure that you and your organizations are capable of managing the submission post approvals.
Our Regulatory Submissions in eCTD trainings will coverĀ 
  • What CTD readiness really means
  • How to understand and follow the CTD structure
  • Which applications need to be submitted electronically
  • How to use the M4 series of guidance and granularity to generate compliant submissions
  • Agency-compliant PDF files and how to generate them
  • Which agency guidelines and technical specifications publishers need to follow
  • What tools are required to electronically submit your applications
  • How to comply with the May 2020 electronic submissions requirements
  • Which agency guidelines and technical specifications publishers need to follow and how to incorporate them into your workflow and QC
  • How to apply ICH and regional requirements to your eCTD
  • What your publishers need from you to compile documents into the XML backbone of an eCTD, and to life-cycle that application
  • How to QC and validate an eCTD
  • How metadata and study tagging files work, and how you can make them work for you and your application
  • Tips, tricks and best practices gathered from industry professionals
  • How to convert from a paper application to an eCTD
  • How the new Module 1 (version 3.3) can be used for regulatory submissions
  • How to generate and use an effective planner
  • How to view eCTD & Successful life cycle management
  • How to dispatch and archive eCTD submissions
  • Regional eCTD M1 requirements and differences (USA, EU, Swiss, Canada, GCC, Jordan, Thailand, Australia, China, Japan, South Africa, EDQM, EAEU)