Success Case B

Manufacturer of world’s 1st biosimilar monoclonal antibody approved by FDA & EMA

Company Profile
Pharmaceutical      I     USD 848.7 Million Revenue     I    1450 + Employees


THE PROBLEM
Business Pains & Challenges

As a global biosimilar manufacturer, the company was in need of a proven, world-class quality management system to address its challenges of :
– being inflexible in adapting to changing quality requirements and market situations
– Replacing paper-based processes with a proven and validated centralized system
– Enhancing time-consuming, error-prone and outdated manual methods of QMS reporting


THE SOLUTION

Vision & Connexo’s Strategy

The company had a clear quality vision to pursue in terms of :
– Deploying a single global quality system for current and future regulatory reporting
– Preventing and eliminating product risks due to inefficient and poor quality management
– Ensuring brand reputation with best-in-class QMS to support company’s sustainable growth

Connexo’s consulting team well understood the vision and successfully implemented its 3-phase cycle approach (Project Planning & Solution Prototyping,  System Implementation & Go-Live Adoption) to fulfill the desired objectives.

THE RESULTS
Benefits & Outcomes

The project was a great success in exceeding, customers’ initial needs and surpassing project expectations, in which Connexo helped customers to achieve :

Business Efficiency
Standardize Critical Processes
Enhanced Customer Satisfaction

  • Single & Unified Quality System of Record.
  • Customer Trust and Confidence in brand image
  • Improved resolution times for processes

 

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