Our CMC department focuses on establishing large-scale synthetic routes along with formulation development and quality control. Our drug categories can be proprietary drugs or generic drugs. All studies are complied with ICH and CFDA guidelines.
Research on Quality Control
The development and validation of analytical method
Develop and validate the analytical method according to the features of dosage form and the APIs.
- Method Validation for Enantiomers
- Method Validation for Impurities
- Method Validation for Content Uniformity
- Method Validation for Assay
- Method Validation for Microbiology
- Dissolution Method Validation
Quality Research of The Products
Quality research base on the character of dosage form and compound and relevant guideline.
- Related Substances
- Dissolution Curve (12 units/lot)
- Moisture or Loss on Drying.
- Microbiological Test
Determine the specification for final products
- Analytical Reports
- Protocol of Quality Standard
- Accelerated and long-term stability test based on ICH guidance and CFDA guidance
- Forced Degradation Testing
- Accelerated Stability Test
- Long-term Stability Test
- The development and validation of analytical method
- Consistency evaluation of formulation by quality specification
- Make solution base on evaluation result
IVIVC of the Product
We provide the service of IVIVC of the product.
Registration and Submission
- Data Processing for the Registration Dossier
- Compiling and Translation of the Registration Dossier.
- Registration & Submission
Our CMC experts with decades of experience are familiar with various ICH and CFDA regulations and guidelines. We have helped many clients to complete their pre-formulation and formulation studies and provided reliable data for the regulatory submissions. We have already successfully assisted many clients to complete the 1.1 class, 3.1 class and 6 class new drugs for CFDA application.