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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Why iVRS

We bring decades of clinical research experience to all our undertakings

◘ Clinical operation team has extensive functional experience of over 100+ years in conducting studies of various indications across therapies

◘ Ability to manage patient pK/pD studies, end point study, new dosage forms, Phase I – IV studies

◘ The project team has worked on small to high complex studies, multi center studies across various geographies (global & intercontinental studies)

◘ Availability of investigator database of various indications

◘ Ability to manage global multicentre clinical studies

◘ Experience in handling medical device studies (Ophthalmic, CVS)

◘ Adherence to recruitment timelines and on time study closeout

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Our Expertise in Analytical Development Includes

◘ Team of scientists with extensive experience in the area of extractable & leachables studies, in vitro bioequivalence studies including IVRT, IVPT, Binding, feeding tube studies, dissolution development and pharmaceutical development.

◘ The team experienced in designing, executing and submitting in vitro bioequivalence studies to various regulatory agencies.

◘ Our team aspire to include every in vitro techniques adopted and recommended for various pharmaceutical dosage forms including oral solid/liquid dosage forms, injectable suspension/solutions, ophthalmic suspensions/solutions/drops, pulmonary aerosols/sprays, dermal products like ointments/creams/gels etc, suppositories/vaginal preparations etc.

◘ Our team believe in thorough, methodical, appropriate research and development in method development, validation and optimization of in vitro techniques and analytical techniques.

◘ Our team meticulously follows the regulatory standards like good laboratory practices, good documentation practices, applicable regulatory guidance, ICH guidelines with adherence to quality & compliance, synchronized with R&D, study conduct and appropriate presentation of data, would lead to faster and easier review by regulatory agencies.

◘ Our team relies on systematic and continuous training, which is key for the operational excellence.

Let us talk

If you are an organization looking to engage a diligent, effective and reputed clinical research organization, you’ve come to the right place. InVitro  esearch Solutions was set up to help organizations like yours achieve integrity, speed and efficiency in your research requirements.

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Location

Bangalore, India

Call Us

+91 80 45500700

Email Us

info@ivrs.org.in