Regulatory Labeling Services - Overview
Freyr offers end-to-end drug Regulatory Labeling Services and software support for global and regional Regulatory labeling management, providing professional assistance in drafting Investigational Brochures (IB), Developmental Core Data Sheets, and Developmental Core Safety Information, creating and updating Company Core Data Sheet (CCDS), core to local product labeling requirements, etc.
Our team of highly qualified medical experts tracks the status of the data sheets’ implementation in local labels, reviews and suggests changes to the data sheets, and drafts the clinical overviews of product labeling requirements for submission to the health authorities.
Freyr's expertise ensures labeling compliance and navigates the complexities of labeling in Regulatory Affairs. We also provide content to carton services for seamless and compliant packaging.
Our CCDS template streamlines the process, facilitating efficient management of core data sheets and local product labeling requirements. Additionally, we harness the power of Artificial Intelligence in Regulatory Labeling Services to enhance accuracy and speed in datasheet implementation and review. With precision and Regulatory adherence, our comprehensive services cater to the evolving needs of the pharmaceutical industry.
Freyr’s Regulatory Labeling Services
Regulatory Labeling Services
- End-to-end drug Regulatory Labeling Services and software support
- Drafting Investigational Brochures, Developmental Core Data Sheets, and Safety Information
- Creating and updating Company Core Data Sheets (CCDS)
- Comprehensive services for global and regional Regulatory labeling management
- Expert review and suggestion of changes to company core data sheets
- Drafting clinical overviews and non-clinical overviews to support label changes
- Utilizing Artificial Intelligence to enhance accuracy and speed in labeling
- Ensures labeling compliance across global Regulatory standards
- Seamlessly manages core to local product labeling requirements
- Tracks status of data sheet implementation in local labels
- Provides precise and Regulatory-adherent content to carton services
- Streamlines CCDS process with an efficient template
- Offers comprehensive solutions catering to the pharmaceutical industry's needs
- Navigates labeling complexities in Regulatory Affairs with expertise
- In-house software and system solutions for labeling compliance and tracking of (Document Management Systems (DMS)
Labeling
