CCDS/CSI Creation & Updation - Overview
CCDS (Company Core Data Sheet) and CSI (Company Standard Information) are critical documents in pharmaceutical labeling. They ensure consistency and compliance across global markets, maintaining accurate product information for healthcare professionals and Regulatory bodies.
Freyr's expertise in CCDS/CSI creation and updation ensures that your product information is meticulously managed and updated according to the latest Regulatory requirements. Our comprehensive approach enhances accuracy, reduces risks, and provides market compliance. Additionally, you gain access to a wealth of expertise and resources that enhance your product's market readiness and safety communication.
CCDS/CSI Creation & Updation
- Drafting Investigational Brochures (IBs)
- Creating Developmental Core Data Sheets (DCDS)
- Updating Company Core Data Sheets (CCDS)
- Reviewing and suggesting changes to CCDS
- Drafting clinical overviews and non-clinical overviews
- Utilizing artificial intelligence for enhanced accuracy and speed
- Ensuring labeling compliance across global Regulatory standards
- Managing core to local product labeling requirements
- Tracking status of data sheet implementation in local labels
- Coordination with CMC and Regulatory affairs teams for compliance
- Expertise in global Regulatory compliance
- High-quality, accurate document creation and updating
- Efficient and streamlined processes
- Timely and precise Regulatory updates
- Customized solutions for unique client requirements
- Reduced risks through meticulous quality assurance
