Documents required for APIs registration

• 1. Application form.
• 2. DrugMasterFile(DMF)
• 3. Stability data for 3 manufacturing series
• 4. Scheme and description of the manufacturing process
• 5. Stability control methods or validation data.
• 6. Quality Certificates for 3 manufacturing series.
• 7. APIs samples (quantity provided by Apteka-95 during registration process)
• 8. Attorney for the registration.

Our Customer returns to us for the next regulatory procedure, if it is a business extension or renewal of registration, and that is our main measure of quality and competitiveness.