2 min read
Now that we have decoded various Regulatory Labeling challenges from different perspectives, is it the time you think to scout for a comprehensive Regulatory Framework? The answer would be a sure shot yes leading to search for innovative products, technologies, solutions, and services the industry is offering. How about choosing an award winning Regulatory Labeling Framework, to streamline and centralize the labeling activities in your organization?
Freyr, a specialized Global Regulatory partner, has established Freyr Global Labeling Xcellence (GLX) Framework to enable organizations uncover potential for managing highly complex, global labeling documents and processes for creating and managing the changes worldwide under well-defined, proactively-intelligent and metrics-driven and technology-enabled environment.
The innovative 3600 GLX framework ensures quality of end-to-end labeling processes from operational, subject-matter and technology perspective. The components of this framework broadly includes:
- Labeling Process Design and Framework
- Labeling Functional Support
- Label Management Technology Implementation
The above mentioned segments further include:
- A well-defined process for creating and managing global label documents
- Managing the changes and deviations in a centralized and streamlined manner
- Defined SOPs for labeling for Consumer Healthcare and Generic industry to suit the fast-paced environment and low margin product portfolio
- Technology solution, Freyr LABEL (Freyr’s in house technology) for global label creation, management and change management
- Creating a centralized repository of institutional knowledge to assist teams with relevant information in real-time
- Intelligence driven regulatory services to ensure market specific nuances are available as well as ensure access to ever changing guidelines
The Freyr’s GLX has been proven in the industry to streamline internal procedures using a part or all of the aspects of the framework. The framework solves key scientific and process-related problems with technology intervention where applicable and avails well-defined processes and KPIs.
In addition, Freyr implements some of the industry best-in-class practices through GLX Framework, which includes:
- Establishing GLM processes with CCDS/CCSI and labeling harmonisation for Generics including comparison with innovator labels
- Establishing processes and parameters for prioritization of source documents for process-efficiency
- Establishing processes to compare the key labels from across the globe and then derived a minimum set of safety information into the CCDS/CCSI
- Establishing processes to track the deviations and coordinating changes and updates in the local labels
- Establishing phased approach for project implementation, clearly defined roles and responsibilities and communication plan. Process for documenting regional nuances, local HA requirements, maintaining knowledge repository, enabling institutional knowledge transfer, experienced based risk assessment and risk mitigation.
- Management of various activities involved within the labeling process, Collaboration between content, artwork, packaging and various other teams, quick and effective label changes based on new guidelines or drug updates.
- Intelligence driven regulatory services and access to institutional knowledge: Centralized knowledge sharing for harmonized approach to global markets
- Robust Pipeline Management
- Phased Approach with increasing Complexity
- Integrated Resource Responsibility Mapping
- Escalation Matrix Inbuilt in the System Workflow
- Integrated Change Planning and Change Communication
- Well Defined Priorities
- Document Management
- Focus on Reusability
In conclusion, adding GLX Framework to your Regulatory labeling strategies can make you navigate the ever evolving global regulatory complexities and streamline the Regulatory procedures, thus to reduce the time and cost for end-to-end compliance.
