Pre-Formulation
- Characterization of original product and active substance
- Compatibility studies of the active substance with excipients
- Risk assessment
Laboratory Scale Studies
- Process selection.
- Development of the laboratory scale production process
- Final formula approval
- Stability
Pilot Scale Studies
- Scale-up production.
- Development of the pilot scale production process
- Pilot batch production
- Pilot batch stability studies
Bioequivalence
- Risk assessment
- Pilot bioequivalence study
- Pivotal bioequivalence study
Licensing
- Registration file compilation for submission to the Health authorities
- Follow-up the submitted files during regulatory process
Supply Chain
- Determination of the appropriate suppliers
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Selection of the most efficient and economical means of transportation
- Management of the import process
- Management of the customs process
- On time delivery