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

Manage labeling data and documents through a single repository

  • Manage, reuse and control product information throughout its lifecycle 
  • Plan and track regulatory activities with labelling impact 
  • Manage country dependencies per product 

Cross-functional collaboration on global and local/country level

  • Automate and connect to the Health Authority or Regulatory Body for approval procedure-specific information and activities 
  • Notifying direct stakeholders and interested parties involved in the regulatory and labeling processes 

Labeling change management oversight and control

  • Label changes submission
  • Assess local and global impact of changes 
  • Handle negotiations 
  • Record and manage exceptions 

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

Find out how we can help you achieve your regulatory compliance goals.  

Connect with our experts today!