Learning management and business process training

Regulatory affairs teams have a constant need of focusing on new changes and requirements from global regions on product launch and roll out. New regulations in major regions impact the overall process for regulatory operations and day-to-day work activities of regulatory affairs and operations departments. Celegence helps to ensure that the members of your regulatory department are trained on latest regulations and related processes, including specific organizational standard operating procedures which are critical for operational quality.

Our team can support the rollout of comprehensive training programs which reflect the latest updates to process, systems, and policies. In addition to this, we also support the management of an end-to-end Learning Management System (LMS), including training charter and curriculum for different roles, scheduling and roll out of various types of trainings,  training records maintenance, onboarding of new members, and refresher trainings.

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

  • Training services to support on-boarding as well as improve skills of existing resources
  • Management of training curriculum and competency matrix to support regulatory operations
  • Training delivery – Web Based Training (WBT), Instructor Led Training (ILT), eLearning through Learning Management System (LMS)
  • Curriculum covers regulatory processes, tools usage, overview of regulations, company specific SOPs etc.
  • Learning Management System to support the ongoing training needs of customers
  • Certification Programs catered towards customer needs

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

PUBLISHING AND ECTD SERVICES

Global Publishing Services and eCTD Conversion

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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