Setting the Standard in Non-Clinical Safety Testing

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45+ Years of Scientific Integrity in Non-Clinical Research

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Global-Standard Safety Testing. From Lab to Regulatory Approval.

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International Institute of Biotechnology and Toxicology (IIBAT)

International Institute of Biotechnology and Toxicology (IIBAT) is a premier contract research organization in India offering GLP-compliant regulatory studies for over four decades. With more than 45 years of experience, we provide end-to-end scientific solutions for agrochemicals, pharmaceuticals, medical devices, biotechnology products, and environmental safety.

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*71+

Employees

*85+

Studies

Who We Are

A pioneer in regulatory science, IIBAT sets the benchmark for GLP-certified testing and global product registration support.

India’s first private laboratory to be certified for GLP by Germany

Certified by NGCMA (India) and recognized by global regulatory bodies

A trusted name for regulatory submissions worldwide

Experts in product registration support, with clients in over 20 countries

Services - IIBAT

1. Toxicology & Safety Assessment

In vitro & in vivo toxicity studies (acute, sub-chronic, chronic)

Genotoxicity & carcinogenicity studies (Ames test, micronucleus, etc.)

Reproductive & developmental toxicity studies

Safety pharmacology (cardiovascular, respiratory, CNS assessments)

2. Chemical Testing & Characterization

Impurity profiling & identification (ICH Q3A-Q3D)

Residual solvents & elemental impurities testing (ICH Q3C, Q3D)

Stability & forced degradation studies (ICH Q1A-Q1E)

Physicochemical property testing (solubility, pKa, logP, particle size)

Polymer & material characterization (for medical devices & packaging)

Household pesticide formulation analysis (efficacy, shelf-life, safety)

3. Pharmacokinetics & Bioanalytical Studies

ADME (Absorption, Distribution, Metabolism, Excretion) studies

Bioavailability & bioequivalence testing

Toxicokinetics & metabolite profiling

4. Ecotoxicology & Environmental Safety

Aquatic & terrestrial ecotoxicology studies (OECD, EPA guidelines)

Environmental fate & degradation studies (hydrolysis, photolysis, biodegradability)

Chemical risk assessments (REACH, CLP, GHS classification)

Pollinator risk assessment (honeybee studies per OECD 213/214)

5. Bioefficacy & Field Studies

Greenhouse & field trials for agrochemicals (herbicides, fungicides, insecticides)

Household pesticide efficacy testing (mosquito coils, repellents, disinfectants)

Dose-response & residue studies (OECD, EPA, WHO guidelines)

Mode-of-action & resistance monitoring studies

6. Medical Device Testing

Biocompatibility testing (ISO 10993)

Extractables & Leachables (E&L) studies

Chemical characterization per ISO 10993-18

7. Regulatory Strategy & Submission Support

Study design & protocol development (GLP & non-GLP)

Dossier preparation (IND, NDA, BLA, MAA, REACH, EPA submissions)

Gap analysis & compliance consulting (FDA, EMA, OECD, ICH, WHO)

8. Customized Testing Solutions

Method development & validation for novel compounds

Specialized testing for agrochemicals, biocides & industrial chemicals

High-purity analytical testing (GMP/GLP compliant)

Our Core Strengths

What sets IIBAT apart is our deep regulatory expertise, scientific precision, and ability to scale complex studies with speed and accuracy. We operate at the intersection of research and compliance, helping clients navigate evolving global standards with confidence. Every study we undertake is backed by decades of experience, rigorous quality control, and a commitment to data integrity.

GLP-Certified Laboratory recognized by India, Germany, and Argentina

300+ validated test protocols across diverse regulatory domains

100+ experienced scientists and PhD researchers leading study execution

Modern vivarium with HVAC-controlled barrier facilities for animal studies

Digitally secured systems ensuring data integrity and audit readiness

Customized study designs aligned with OECD, EPA, FDA, and REACH guidelines

Events & Research

We regularly host knowledge-sharing webinars and scientific symposia on GLP, regulatory frameworks, AI in science, and environmental challenges. Our commitment to scientific education and doctoral research makes us a knowledge hub as much as a testing lab.

Preparing for Future Pandemics

Role of AI in Scientific Research

Data Integrity in GLP Studies

Environmental Threats & Regulatory Response