Support in developing the process and analytical methods, and obtaining data for application.
Support in planning and exposing the tasks of the overall schedule from development to filing the product.
GMP compliance review of the facility, installing new equipment, technical transfer and scaling up.
Support in improving the process robustness and product quality.
Planning and supporting the GMP documentation including SOPs, documents for regulatory filing and building company structure.
Support in preparing and applying for regulatory approval, including response to the regulatory.
Supporting from initial education of GMP regulation and know-hows for process development.
Supporting validation of equipment, regular validation and process validation.
Manage the project on behalf including schedule management and being the center of communication.
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Nexredge accelerate the development of the research seeds of biological drugs and “human cell therapy and gene therapy products” based on biotechnology by supporting the process development and commercialization in accordance with the GMP guidelines and pharmaceutical regulations.
We offer comprehensive and highly specialized support in plant construction, development in manufacturing process and the machinery, building the organization, GMP and pharmaceutical applications.
Our goal is to provide a service that change the method of biopharmaceuticals development.