Technical services
Our services include:
- Provide technical support for process improvements and troubleshooting for API synthesis, intermediates, and drug products.
- Offer technical service of identification, characterization, preparation, and qualification Impurities, polymorphic study, improvements in analytical methods, troubleshooting, and supporting to regulatory queries responses,
- Provide technical support for the development of discriminatory dissolution method and establishment of in vitro-in vivo correlation/relationship (IVIVC /IVIVR).
Scientific report writing
Drug product
- Drug product formulation development reports
- Drug product manufacturing process development reports
- Investigation reports
- Characterisation reports
- Criticality assessment reports
- Transfer reports
- Any writing activity involving protocol & report writing
Drug substance
- Criticality analysis report: Quality by Design approach (QbD), identification of Critical Quality Attributes (CQA) and Critical Process Parameters (CPP)
- Origin and fate of impurities during the drug substance process
- Regulatory starting material justification
- Registration campaign report
- Process development report
Analytical development
- Stability reports
- Analytical method development reports
- Dissolution transfer reports
- Microbial method transfer reports
- Reduced testing Pharmacopeia methods & justification reports
