Accelerating the development with the attentive help of your needs.

[Our Business]

Development of Clinical Drugs

Development of Clinical Drugs

Support in developing the process and analytical methods, and obtaining data for application.

Development Support

Development Support

Support in planning and exposing the tasks of the overall schedule from development to filing the product.

Engineering Support

Engineering Support

GMP compliance review of the facility, installing new equipment, technical transfer and scaling up.

Improvement of manufacturing process

Improvement of manufacturing process

Support in improving the process robustness and product quality.

Documentation

Documentation

Planning and supporting the GMP documentation including SOPs, documents for regulatory filing and building company structure.

Regulatory Discussions

Regulatory Discussions

Support in preparing and applying for regulatory approval, including response to the regulatory.

Employee Education / Training

Employee Education / Training

Supporting from initial education of GMP regulation and know-hows for process development.

Validation

Validation

Supporting validation of equipment, regular validation and process validation.

Project Management

Project Management

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.

[Nexredge solution]

  1. Providing solution and advices on development and investigating and provide solutions for technical difficulties for biologics (including biological drugs and “human cell therapy and gene therapy products”)
  2. Providing support and plans for manufacturing process including scale up in accordance with the pharmaceutical regulations such as GMP guidelines.
  3. Engineering and validation support for GMP compliant manufacturing plant.
  4. Other biological product related hands-on supports.