eSTAR - Electronic Stability Testing Analyses & Reporting
EAPHARMICS eSTAR stability software completely supports the stability studies of Investigational New Drug Applications (IND), New Drug Applications (NDA) for both New Molecular Entities (NMEs) and Non-NMEs., New Dosage Forms, Abbreviated New Drug Applications (ANDAs) and Post Marketed Annual Stability Products for the drug substances and drug products.
EAPHARMICS eSTAR stability software easily manages thousands of stability studies with extremely intuitive browser based user interface that allows the user to access multiple levels of details with the powerful security features of ORACLE database.
EAPHARMICS eSTAR stability software
is a fully validated software system. It combines the ease of use of an
object oriented browser style user interface and industry standard document
that meets the regulatory requirements reporting systems. Drug stability
studies are managed with more efficiency using EAPHARMICS eSTAR stability
software's combination of multilevel features that helps to reduce the
CGMPs operational errors, deviations and maximizing the regulatory approvals.....
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