Scientific Report Writing

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.

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