Generics Consistency Evaluation Services
According to Drugs Register Regulation issued in 2007 , re-evaluation on the quality of launched oral solid drugs is requested, with the purpose to perform the assessement on quality and efficacy of drugs. The key re-evaluation measures are the comparision of dissolution rate, related impurities , and bio-equivalance. Re-development is requested under the condition of inconsistence is exsisted.
Baolong can provide the follwoing consistency evaluation services on generic drugs for solid oral and parenteral formulations：
- Prepare documentations to import &filling reference drugs
- Screen and select qualified supplier of API
- Perform supplementary studies to upgrade API quality
- Perform formulation optimization and studies for process control.
- Perform studies on dissolution profile similarity with RLD in different medium
- Perform studies on impurities profile, including impurity identification and elemental impurity study.
- Perform studies on stability, package compatibility and safety evaluation, etc.
- Perform scale up study and process validation in GMP plant.
- Prepare and submit registration dossiers to CDE
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