Services Offered
Pre-formulation studies Dossier compilation
Formulation development Dossier filing and communications with regulatory agencies
Analytical development Admixture studies method development and validation
Analytical method validation Photo stability studies
Cleaning method development Stability studies
Cleaning method validation Freeze thaw studies
CCIT method development and validation Temperature excursion studies
Technology transfer to manufacturing site Extractable and leachable study
CMO identification Ink and glue migration studies
CMO audit as per regulatory requirement US Agent and consultancy services