Product Development

Preformulation and Formulation Development

• Excipient identification and compatibility studies
• Physical property characterization
• Formulation development
• Pilot scale manufacturing
• Process development and scale-up
• Commercial formulation development

Scale-up and Pilot Batch Manufacturing

• Manufacturing of the registration batches
• Testing of registration batches
• Stability study design and monitoring using International Conference on Harmonization (ICH) guidelines
• Documentation provided in submission ready format
• Validation master plan, protocols and reports
• Regulatory support from scale-up to commercialization

Analytical Development

The equipment are used for characterization of active pharmaceutical ingredients (API) as well as method development and quantitative and qualitative analysis of variety of dosage forms.
Analytical development services include:

• Characterization of API
• Method development and validation
• Dissolution and drug release profiling
• Stability and degradation studies
• Dosage specifications development