1。The development and validation of analytical method
Develop and validate the analytical method according to the features of dosage form and the APIs。
2。Quality research of the products
Quality research base on the character of dosage form and compound and relevant guideline。
3。Determine the specification for final products
We provide the service of IVIVC of the product.
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.