Results
Quality System and Regulatory Affairs
Tianshu Pharmaceutical aligns its drug production quality management with international standards. Its factory facilities are designed and constructed in strict compliance with relevant guidelines and regulations such as cGMP and ICH

The company has built independent clean workshops and a quality control & R&D center (including a clean area for microbial testing). It is equipped with various internationally advanced analytical and testing equipment, such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Infrared Spectroscopy (IR), and particle size analyzers. Combining practical conditions, Tianshu Pharmaceutical has established quality management systems and has a mature quality management team.

  • Quality Management
  • Production Management
  • Laboratory Management
  • Packaging and Labeling
  • Material Control
  • Equipment and Facility Management
  • Data Integrity
  • Continuous Process Validation
  • Computerized System Validation
Quality Policy

Quality first, Scientific management, Continuous improvement and Customer satisfaction

Operation of the Quality System

Tianshu Pharmaceutical strictly complies with GMP requirements in the operation of its quality system, ensuring that all links such as personnel, machines, materials, regulatory, and environment throughout the production process are effectively controlled, and that product quality is stable and reliable.

  • SMP
  • SOP
  • STP
  • URS
  • RAP/R
  • PRO
  • REC
Regulatory Registration

Tianshu Pharmaceutical has set up a dedicated Regulatory Affairs (RA) department. The RA team boasts rich experience in international API registrations as well as API registrations in high-end regulatory markets such as the CEP, ASMF , JDMF, KDMF, RuDMF and etc.. It can independently complete or cooperate with customers to manage the entire project registration process, including the preparation of registration dossiers or supplementary documents for new drug IND, NDA, ANDA, tracking of review progress, and response to deficiencies.

Quality Audit and Registration Verification

Since its production began in 2023, Tianshu Pharmaceutical has undergone more than 100 on-site quality system audits by well-known domestic and international pharmaceutical companies from China, India, Europe, Japan, etc., and has passed the on-site inspection conducted by the Center for Drug Evaluation of the National Medical Products Administration.