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Regulatory Labeling
Security, quality, speed and worldwide compliance
When we talk about labeling management, we very often talk about complexity and long processes. Within the landscape of growing R&D ambitions, market expansion and both country-specific and global regulations, the labelling management burden in life sciences is multiplying at a pace. Life Sciences organizations need a systematic, centralized approach to ensure their labeling process is executed correctly and efficiently across markets.
End to end international packaging and labeling management
Amplexor’s wide-ranging experience can help you market your products anywhere in the world. With a deep industry and regulatory know-how, combined with cutting-edge technology, we understand how critical accuracy and safety are for international labeling.
Amplexor LabelExpert™ 5.0
A complete labeling management solution to support end-to-end labeling processes, change requests, sequences and templates, including assessments, revision, approval and tracking.
Labeling Process Management
Support labeling processes end-to-end, including change management and compliance tracking
Labeling Content Management
Labeling data and product information management at local and international level
Labeling Report Management
Automated notifications and powerful search capabilities
Features
Complete labeling traceability, for compliance, reporting, and safety/risk management
An end-to-end solution to support Product Information and Labeling departments to manage labeling documentation
Success story
It can be a complicated and high-risk situation for pharma companies that must translate labels into several different languages. Find out how Amplexor helped a Fortune 100 pharma company address these challenges and achieve full global compliance.
Benefits
A collaborative interface environment for worldwide consistency
End-to-end traceability and consistent process control
Central master data repository capable of supporting multiple applications
Harmonize and automate labeling management
Standardize processes and oversee labeling changes and their implementation
Reduce rework and improve reporting
Combining product master data with regulatory intelligence
Increase productivity and efficiency
Reuse or repurpose approved content from a central resource
Minimize the risks of non-compliance
Support regulatory requirements through a validated solution
Featured content
End to end regulatory information management
Amplexor labeling management solution can be integrated with other solutions for thorough regulatory planning and tracking:
Document Management
Content management of labelling and product information documents
Product Data Management
Extended EudraVigilance medicinal product (xEVMPD) data management
Regulatory Assessment
Impact assessment, submission planning and registration tracking
Submission Management
Submission compilation and global and local submission publishing