Pre-formulation and formulation
- Characterization of raw materials.
- Pre-formulation activities
- Definition of formulas
Manufacturing of pilot-scaled batches
Transfer of technology
We provide support throughout the entire process of transferring your product to our plant, providing a comprehensive, high-quality service.
- Feasibility assessment
- Preparation and agreement of transfer
- Timeline of transfer and activities monitoring
- Execution of the analytical transfer
- Preparation of transfer batches
- Validation of the manufacturing process
- Stability study
- Preparation of the technical dossier
- Implementation of the commercial product process
- Transfer approval and closing
Staggering of manufacturing processes
- Accellerated studies 40°C/ 75% HR: For ongoing product monitoring, packaging evaluation, six months.
- Long-term studies Zone II, Zone IVA, Zone IVB: Shelf-life verification stability.
- On-going stability or shelf-life monitoring stability.
- In-use stability
To achieve the best results possible, in Altea Farmacéutica S.A. we innovate every day using the best technologies of the pharmaceutical industry.
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