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Optimizing regulatory submission process

Regulatory organizations experience challenges in managing information and correspondence associated with global submissions and product registrations. Outsourcing partners also need to be managed and the appropriate regulatory filings must be updated and approved by health authorities prior to implementation to ensure compliance.

Partnering with our regulatory optimization experts ensures your organization implements optimal procedures for planning submissions, authoring, review and approval, managing health authority correspondence and commitments, and integrating with change control processes.

Achieving your RIM vision: CGI’s RIM framework

CGI’s RIM framework facilitates the development of a future state RIM strategy and roadmap for managing regulatory information across your organization. Our framework addresses the people, process, information and technology aspects of the RIM vision, and ensures alignment among executive and business leaders. It provides a path forward to effectively manage the following:

  • Global product registrations and manufacturing changes throughout the product life cycle
  • Health authority correspondence and commitments
  • Regulatory submissions, labeling, and promotional materials
  • Pharmacovigilance and adverse events
  • The latest regulatory intelligence
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Addressing the full spectrum of RIM

CGI’s RIM framework enables life sciences organizations to automate and streamline processes and establish best practices in the following areas:

Registration management
Regulatory intelligence

Keep your finger on the pulse of new regulations, what they mean, and what others are doing to address them.

Labeling management

Manage XML labeling content creation and revisions across versions and countries.

Pharmacovigilance management

Proactively manage adverse events and report to appropriate stakeholders.

Submission planning and management

Integrate submission plans with product development plans to reduce time-to-market and improve collaboration and process integration of document authoring, review and approval.

Correspondence management

Effectively manage regulatory correspondence and notifications.

Commitment management

Receive notifications to keep track of regulatory commitments and ensure they are met.

Promotional materials management

Effectively manage the entire life cycle of promotional materials from creation through dissemination and retirement.

Chemistry manufacturing and control (CMC) management

Understand the impact manufacturing changes have on regulatory filings and ensure appropriate approval by health authorities before implementation.

Benefits of an optimized RIM strategy

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  • Faster time to market via more efficient and effective submission and correspondence management
  • Greater business productivity resulting from having more time to focus on other activities and simplified business process interactions with external service providers
  • Increased visibility into global regulatory activities (e.g., what submission was filed in what countries, what commitments were made and when are they due, health authority correspondence, and changes in regulations or interpretations)
  • Enhanced compliance with product registrations and more consistent health authority interactions

CGI’s solution capabilities

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  • Promotional materials management
  • eSubmissions and electronic common technical documents (eCTD)
  • Electronic trial master file optimization
  • Good x practice (GxP) quality systems
  • Enterprise content management strategy and implementation
  • Big data analytics
  • Information governance
  • Content migration and cloud readiness
  • Content imaging and scanning solution implementation