Alternate API qualification. Gap assessment and remediation of analytical methods (LCM approach). Investigation support for Mfg site. In use stability study for regulatory bodies.Analytical equipment qualification.Method equivalency studies.Compendial method verification activity. Review of analytical data. Preparation, review and approval of scientific/ validation protocols and reports.Review & approval of equipment qualification protocols , associated reports and system audit trial report.

Alternate API qualification. Compendial method verification. Gap assessment and remediation of analytical methods (LCM approach). Investigation support for Mfg site. Implementing reduced testing program.In use stability study.Analytical equipment qualification. Analytical support to address the regulatory queries. Support for FR&D stability study.

Implementation of Custom field calculation in Empower software. Analytical support forExhibit batch stability samples. Preparation of stability protocols and reports. Preparation of stability trending reports. Co-validation of analytical HPLC and Gas chromatography methods.Calibration of analytical equipment’s. Developmental stability study and Exhibit batch stability studies for injectable formulations.

Analytical support for Exhibit batch stability samples. Preparation of stability protocols and reports. Support for In-use stability study for Exhibit batch stability samples. Analytical equipment qualification. Implementation of Thermo LIMS for stability management.Developmental stability study support.

Analytical method validation, verification and transfer for oral solid dosage form. Analytical Method feasibility studies.Conducting multi media dissolution profile for Bio study.Analysis of Exhibit batch and commercial quality control samples.Analytical support to address the regulatory queries.