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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

 

 

Consulting Services

Analytical Research and Development

Quality/Regulatory Compliance

Teaching, Training and Coaching

 

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