Successfully completed USFDA Inspection of our Analytical Laboratory
Executed 360-Participant clinical study in Pain Management
Completed Atopic Dermatitis clinical study for Health Canada, leading to successful regulatory approval.
Successfully executed Phase I NCE Clinical Study
Successfully completed Sevelamer Carbonate API sameness study for TGA.
Executed NG and G-Tube studies for Health Canada and USFDA, with successful regulatory approval from both agencies
Completed 250+ Extractable & Leachable Studies
Showing Slide 1 of 7: Successfully completed USFDA Inspection of our Analytical Laboratory
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Q1 & Q2 Sameness
Other analysis of samples using various analytical techniques will be carried out at iVRS using state of the art infrastructure. Other analytical services includes elemental impurity analysis, nitrosamine & other mutagenic, non-mutagenic impurity analysis.