FEE&C Service for MNC Insulin Project

Recently AUSTAR has signed a consulting service contract with a leading global healthcare company and a prominent player in the insulin market. Collaborating with the client, we will provide comprehensive consulting and process engineering services, complying with international quality standards, and implementation of sustainable development strategies. As the market continues to expand, drug profiles improve, indications broaden, and competition intensifies, GLP-1 therapies are expected to become the mainstream treatment for diabetes and obesity in the years ahead—and the top single-product sellers in their class.. - Product:Insulin & GLP-1 - Project standard:EMA, FDA, NMPA cGMP - Facility type:Greenfield - Project area:25000 ㎡ - Project-Driven:Rapidity, compliance

AUSTAR Solution

Service Scope: • Providing comprehensive solutions for process systems • Process system URS review • Quality risk management based on EU Annex 1 • Knowledge transfer between process and engineering • Interface definition during design and construction for process systems • Commissioning and validation of process systems
Expectation & Challenges: • Quality standards of MNC pharmaceutical companies • Collaboration and technical communication with multinational project teams • Isolator process technology solutions • Concurrent progress of projects in the United States, Europe, and China • SRA - Science & Risk-based Approach

AUSTAR Value & Client Benefits

• Comprehensive solutions based on AUSTAR’s 12 applications • Process engineering capabilities of AUSTAR SME team • Project experience from MNC pharmaceutical companies, with FDA, EMA, NMPA standards

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