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CARA Life Sciences Regulatory Logo copy.

Labelling

End-to-End Labelling Management

Labelling

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Learn more about managing the RIM process on the Platform

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Learn more about managing the RIM process on the Platform

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Labelling on the CARA Life Sciences Platform simplifies your processes and automates the traditionally complex challenges. 

Challenges Managed:

Working with all types of documents - Core Data Sheets to Individual Labels

Automating Translation Process

Regulatory Affairs Interactions (Internally and with Health Authorities)

Changing Industry Regulations

Interacting with Product Supply

Learn about managing correspondence in our RIM solution

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HOVER

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Dive into Quality on the CARA Life Sciences Platform!

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Regulatory Intelligence Management is coming soon!

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Company Core Data Sheet (including building from data)

Update components based on 'where used' tracking 

Generate labels in MS Word, PDF, or Component-Based Authoring

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Learn more about submission content management on the platform

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Trigger and manage Change Requests (HA Request, Safety Trigger etc.)

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Learn about managing correspondence in our RIM solution

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Correspondence & Commitments

RIM

Generate translations and automate relationships and workflows

Portal for Print Shops & Affiliates

Submit, track HA status, manage correspondence, registration

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Learn about managing correspondence in our RIM solution

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RIM

Create and manage Artwork and Product Packaging

Authoring

• Create template components or documents

• Build a complete document from the these components

• Reuse components across documents (from Core Data Sheet to Labels, PI etc)

• Compare labels (e.g. master label and derived label)

• Reconcile local market changes back to the master label

• Build labelling documents using data from other disciplines e.g. Clinical, ensuring that updates in the source data flags the requirement to update labelling documentation

Submission

• Use the labels directly in the CARA Regulatory Submission documents

• Easily track which versions of which components or compiled labelling documents were submitted where, when, and whether a regulatory change request must be reflected in other markets

• Push labelling information through to Product Supply and artwork production

• Output files in format required by different regulatory authorities

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Learn about submission documents on the CARA Life Sciences Platform

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Learn about submission documents on the CARA Life Sciences Platform

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Learn about submission documents on the CARA Life Sciences Platform

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Use & Maintenance

• Push labelling information through to Product Supply and artwork production

• Create Change Requests using the CARA QMS to manage ongoing changes

• Manage production options (continue using existing packaging, destroy all packaging etc)

• Automate translations

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Learn about change requests with QMS on the CARA Life Sciences Platform

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Structured Content Authoring

Author individual components that are collated into single labels

Submission & Product Integration

Seamlessly integrate the labelling documents with both labelling production systems and submission systems

Where Used

Easily track and trace where each version of each label has been submitted and approved during which date period

Reconcile Multiple Labels

As labels are changed in local markets, identify changes and reconcile back to master labels

Translations

Manage translations of labels including providing a portal access via CARA to translation companies

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Learn about our RIM on the platform

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