Regulatory

About Regulatory

Quality and Compliance of all 6 systems namely Quality system, Production System, Material System ,Equipment and Utilities System, Laboratories Control System and Packaging & Labelling System is in place for Plant, R&D and Regulatory Affairs

The company has successfully concluded all three consecutive USFDA inspections.

Such inspections had also included PAIs (pre-approval Inspections) leading to recommendation for approval of PAI products which have been approved.

Company is already equipped to meet the new USFDA requirement for Track and Trace System for packaging (serialization) effective from November 2018, and is already implemented.

The company is committed to continue to strive for sustained and full compliance.