Analytical Research and Development
 Strategic planning and project management
- Design and plan analytical development strategy
- Lead projects through every stage of it's life cycle, from
pre-formulation to approval
- Resources planning and instrument selection
- Recommendations for recruitment
Pre-formulation studies
- Design compatibility studies, dissolution method development and physico-chemical characterization
Analytical method development and validation for the global market
- Select analytical technique
- Design method development/validation for stability indicating assays and related substances/degradation products, residual solvents, cleaning assays and discriminative dissolution methods
Master documents design
- Specification/Certificate of Analysis for drug substances and drug products
- Analytical testing procedures
- Method validation protocols and reports
- Stability protocols
Testing requirements for drug substance and drug product for the
 global market
API and reference standards qualification
In-vitro bioequivalence studies/essential similarity for global market
Deficiency letter responses to various government agencies
Preparation for the pre-approval inspection
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