Labeling & Manufacturing
Our drug labeling standards are designed to outline the conditions of use and the labelling requirements. The product and its labelling have to be consistent with the information set out in the drug submission documentation. Our staff can help you design the labels according to the local regulations.
Our contract manufacturing services are designed to find, select and help a company that has a new design or a new formula to approach a contract manufacturer. We can guide you to receive from the contract manufacturer a quote based on exact procedures, labor, tooling, and material costs. Our staff can help you, select the best price under the best circumstances.
Active Substances Registration
- Drug Master File Preparation
- Scheme and description of the manufacturing process
- Stability data on manufacturing batches
- Control method of the stability or validation
- Certificates of quality on manufacturing batches
- Samples of the substance
- Power of attorney
Medicinal Products Registration
- Registration of Generic Products
- Registration of Original Products : MRP, CP, DCP
- Renewal of registration
- Changes Type A
- Changes Type B
