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

The changing regulatory landscape is vast, especially when companies with complex product portfolios need to expand beyond just a handful of regions. Launching new products and rolling out existing products to new regions becomes a huge task for regulatory affairs teams. Furthermore, product lifecycle management and addressing changes in regulations only adds more complexity.

Celegence helps clients navigate increasingly complex and stringent global regulatory requirements while improving and standardizing processes across functions and geographies.

Our global regulatory experts offer broad strategic knowledge that delivers and active regulatory agency network giving local coverage in global markets. That coverage enables us to apply up to date, robust regulatory intelligence to product development and registration strategies.

Celegence is also developing a international database solution to help the life sciences industry monitor global requirements, share information, and ultimately manage Regulatory strategy for a complex product portfolio. This collaborative solution will help Regulatory Affairs teams collect, store and share regulatory information based on previous submissions, experience, and regulatory monitoring allowing you to benefit from valuable information in future submissions.

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

  • Provide intelligence on regulatory requirements in the context of submissions for clinical trials, marketing authorization, post marketing maintenance, global and regional regulations
  • Prepare regular impact analysis reports to help your organization understand how changing regulations impact product portfolio
  • Reports on current trends related to regulatory operations, interpretation of regulatory information to improve processes, and KPIs
  • Define regulatory submission strategy based on internal data and current/future regulations specific to product types, therapeutic areas, geographical regions etc.
  • Global and local regulatory submission consulting to aid companies with defining and monitoring regulatory submission plan
  • Centralized repository for internal and external regulatory intelligence documents

 

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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