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British Dragon Pharmaceutical can prepare documentation and sample for drug marketing authorization containing:
- GMP Certificate
- Active ingredients
- Manufacturing method
- Product literature and Complete drug formula
- Product labeling, packaging and storage condition
- Manufacture license
- Product sample
- Toxicological and Pharmacological documentation
- Clinical trials, safety trials
- Free sale Certificate
- Raw material specifications of active and inert ingredients with the corresponding control methods in details
- Finished product specification with the corresponding control methods in details
- Certificate of analysis of active ingredient
- Product analytical control method
- Stability studies of finished product