iVRS

iVRS News

Successfully Completed 100 + Extractable and Leachable (E & L) Studies.

Extractable & Leachable Studies conducted at iVRS has been approved by USFDA and Health Canada.

In Vitro Release Test (IVRT) Studies conducted at iVRS has been accepted by Saudi Food and Drug Authority (SFDA).

Successfully completed PK based bioequivalence study of Cladribine in RRMS Patients for Jordan Food and Drug Administration (JFDA) submission.

Rich Experience in Handling Global Biosimilar Studies.

Successfully Completed Global Ophthalmology Device Study.

Our Process and Systems are ISO 9001 & ISO 27001 Compliant.

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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