EirGenix is a contract development and manufacturing organization that provides high-quality and cost-effective service.  We support our clients in the development, analytical testing, and cGMP manufacturing of biopharmaceuticals from pre-clinical to commercial manufacturing. EirGenix also specializes in the development of biologics, specializing in the development of biosimilars.

Our Services:
- Cell Line Development (mammalian/microbial systems)
- Process Development and Process Optimization
- Analytical Services and Quality Control
- cGMP Manufacturing (mammalian/microbial systems)
     - Taiwan FDA inspected/approved
     - Japan PMDA inspected/approved
     - U.S. FDA inspection pending (June 2022)
     - EMA inspection pending (2022-2023)
- Antibody-Drug Conjugate (ADC) Development and Manufacturing

Biotechnology

Manufacturing

Pharmaceutical

EirGenix, Inc.

Lee-Cheng Liu

Thomas Schulze

This department focuses on advancing knowledge and innovation through systematic investigation and analysis.

Research and Development

The Business Development team at EirGenix, Inc. is responsible for identifying and pursuing new business opportunities to support the company's growth and expansion in the biopharmaceutical industry. This involves building and nurturing relationships with potential clients, negotiating contracts, and developing strategic partnerships. The team also works to understand market trends and client needs to position EirGenix's services effectively, ensuring the company remains a competitive and innovative leader in biopharmaceutical development and manufacturing.

Business Development

The Quality and Regulatory Affairs team at EirGenix, Inc. is responsible for ensuring compliance with global regulatory requirements and maintaining the highest standards of quality across all operational processes. This includes overseeing analytical testing, quality control, and adherence to cGMP manufacturing practices. The team works to ensure that all products meet stringent international quality and safety standards, facilitating successful regulatory inspections and approvals.

Quality and Regulatory Affairs

This department ensures that products meet specified quality standards through rigorous testing and evaluation processes.

Quality Assurance

This department manages compliance with regulations and guidelines relevant to the organization’s products and services.

Regulatory Affairs

This department oversees clinical trials, operations, and medical affairs related to drug development.

EirGenix, Inc.

Org chart

Teams

Research and Development

Business Development

Quality and Regulatory Affairs

Quality Assurance

Regulatory Affairs

Clinical Development

Offices

EirGenix, Inc.

Org chart

Teams

Research and Development

Business Development

Quality and Regulatory Affairs

Quality Assurance

Regulatory Affairs

Clinical Development

Offices

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