Scientific Report Writing Services
At Ardena, we are experts in writing scientific and technical reports using a dossier-centric approach. This means we keep the final dossier submission in mind throughout to ensure consistency, completeness and readability.
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Our scientific report writing services include:
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)
- FMEA, control strategy for the drug substance process
- Origin and fate of impurities during the drug substance process
- Regulatory starting material justification
- Registration campaign report
- Process development report
- PAR justification report
Analytical development:
- Stability reports
- Dissolution transfer reports
- Microbial method transfer reports
- Reduced testing Pharmacopeia methods & justification reports
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