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