Medicilon CMC Services

he development and validation of analytical method

Develop and validate the analytical method according to the features of dosage form and the APIs.

1. 1)Method validation for enantiomers
2. 2)Method validation for impurities
3. 3)Method validation for content uniformity
4. 4)Method validation for assay
5. 5)Method validation for microbiology
6. 6)Dissolution method validation

2.Quality research of the products

Quality research base on the character of dosage form and compound and relevant guideline.

1. 1)Identification
2. 2)Assay
3. 3)Enantiomers
4. 4)Related substances
5. 5)Disintegration
6. 6)Dissolution
7. 7)Dissolution curve (12 units/lot)
8. 8)Moisture or loss on drying.
9. 9)Microbiological test

3.Determine the specification for final products

1. 1)Analytical reports
2. 2)Protocol of quality standard

Stability Study 

• Accelerated and long-term stability test based on ICH guidance and CFDA guidance
• Forced Degradation Testing
• Accelerated Stability Test
• Long-term Stability Test

Consistency Evaluation 

• 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 

1. Data processing for the registration dossier
2. Compiling and translation of the registration dossier.
3. 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.