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

In a competitive market, regulatory operations teams are focused on achieving global growth, which requires redefining their operating model by adopting strategic resourcing where resource requirements for new product approvals can be balanced with the demands of maintaining compliance of established products. As regulatory requirements become more and more complex, requiring more in depth knowledge and increasing staffing needs, organizations must evolve their regulatory operations operating model to execute with speed and at scale.Through a flexible team model that combines operational and strategic expertise, Celegence guarantees increased efficiency by providing end-to-end regulatory operations services ranging from product registration to post-approval maintenance.

With our depth of expertise and extensive delivery capability, Celegence is able to drive sustainable outcomes such as scalable resourcing, faster speed to market, improved compliance and process excellence.

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

  • Global product life-cycle management through RIMS application and related software tools
  • Global regulatory publishing and submission management including marketing authorization, variations, and labeling
  • Pro-active end to end data processing related to RIMS with outsourced model
  • Help organizations to improve submission quality, regulatory compliance, adopt to new data standards
  • Managed services based resource staffing and comprehensive training of assigned resources specific to customer processes and tools
  • Meet geographical needs of the customer with flexible working hours

Operational challenges like cost, resources, quality are managed with clear SLAs and OLAs

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

IDMP & COMPLIANCE CONSULTING

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

REGULATORY INTELLIGENCE SOLUTIONS

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

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