公司历程-关于我们-楷拓生物

CATUG Biotechnology focuses on gene therapy and nucleic acid drug innovation technology, provides one-stop services from R&D, clinical trials to commercial phase, and applies the quality management system in line with ICH, FDA, EMA, and NMPA GMPs. Our quality system team and registration team keep tracking the latest news in global policies and regulations, and are capable of providing flexible, professional and efficient IND application services.

IP Management

- Double confidentiality agreement, stipulating confidentiality obligations

- Strict electronic file management system, effectively supervising the full life cycle of data

- Sophisticated computer IT technical means, isolating the office network from the business network, and restricting users from batch querying, exporting, copying or accessing customer information

- Perfect project management mechanism to effectively protect customer project information

Compliance Management

- Quality management：CATUG has a quality system applicable to CDMO business, precisely formulates the quality control strategies at each phase, applies independent DMS and QMS, and effectively separates management at R&D and GMP phases to ensure that data and documents are not crossed and confused.

- Registration management：CATUG has an experienced registration team that keeps tracking the latest news in relevant global regulations and policies, interprets information in depth to avoid problems while preparing registration.

- Safety management：CATUG focuses on business scenarios, and guarantees business safety. The EHS system applicable to CDMO business has established a safety production model and a personalized safety evaluation model in compliance with the platform process to improve the business efficiency.

Technical Management

- Mature plasmid development process platform

- Flexible RNA development process platform

- Multi-path delivery encapsulation process platform

- High-sensitivity analysis and detection platform

GMP Management

- Complete GMP management system and structure, complying with ICH, FDA, EMA and NMPA GMPs to escort drug applications.

- GMP quality system documents in both Chinese and English, shortening the period of submission dossiers preparation in many places.

Operation Management

- Ensure the timeliness of business operations for customers.

- Manage suppliers to purchase material for projects, improving business efficiency.

- Housekeeper-type project management mode to ensure the orderly progress of the project by dual systems based on multi-layer mining of customer demands and multiple rounds of confirmation.