Consulting services to improve operational efficiency and support strategic initiatives

The regulatory affairs departments of life sciences companies need to have an especially clear definition of responsibilities and accountabilities to ensure effective and efficient product lifecycle management. Increasing regulatory complexities demand a clear definition of process, usage of technology, organization structure and management of regulatory information including compliance data.

Celegence can help organizations to reform in terms of technology, process, structure and quality for regulatory affairs department. Our experienced consultants can help in defining global process for increased effective collaboration, transparency, workload management, efficient management of budget, increased data quality and support companies to evolve.

We help organizations to transform data into information, information into knowledge and utilize knowledge for continuous improvement through specialized subject matter consulting.

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

  • Regulatory Affairs consulting for Pharmaceutical, Medical Devices, Vaccines, Cosmetics and Biologic products
  • Advisory consulting on process and platforms to improve quality, compliance and efficiency
  • Solution agnostic process-oriented consulting for Regulatory Affairs
  • Business process definition and optimization
  • Assessment of “AS-IS” and definition of “TO-BE” Solution landscape

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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