Dossier for registration of substance:

1. Application for the registration (text of Application will be provided by Bureau Cratia Ltd.).
2. Drug Master File.
3. Scheme and description of the manufacturing process.
4. Stability data on 3 manufacturing batches.
5. Control method of the stability or validation.
6. Certificates of quality on 3 manufacturing batches.
7. Samples of the substance (exact quantity of the substance will be provided by Bureau Cratia Ltd.)
8. Power of Attorney (text of Power of Attorney will be provided by Bureau Cratia Ltd.)