iVRS

iVRS News
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
Analytical Laboratory Services - Extractables & Leachable

Extractable & Leachable Studies

iVRS successfully submitted 100 + studies to various regulatory authorities and several studies have been approved by USFDA, Health Canada and EMA.

iVRS offers extractable and leachable testing services through cGMPcompliant procedures. Studies of extractable and leachable components within container closures system are required to meet the safety requirements for marketed medicines. iVRS carry out E/L studies for a wide range of drug products in a variety of packaging types, conducted in accordance with various guidelines such as PQRI guidance, USP general Chapter, EMEA etc. We have worked on the following therapeutic indications for USFDA, EU, GCC and Health Canada:

◘ Aerosols

◘ Semi solid

◘ Oral liquids

◘ Injectables

◘ Ophthalmic

In addition to the studies, we also support for identification of leachable compound(s) if any, and for assessment of safety and toxicological assessment of identified leachable(s).

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Address

Bangalore, India

Call Us

+91 80 45500700

Email Us

info@ivrs.org.in