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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.
Most popular related searches
drug production
drug substance
drug development
drug formulation
drug manufacturer
drug development process
drug analysis
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