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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Employees

Studies

Scientists conducting analytical testing and research using advanced laboratory instruments in a biotechnology facility

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

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)

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)

Pharmacokinetics & Bioanalytical Studies

ADME (Absorption, Distribution, Metabolism, Excretion) studies

Bioavailability & bioequivalence testing

Toxicokinetics & metabolite profiling

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)

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

Medical Device Testing

Biocompatibility testing (ISO 10993)

Extractables & Leachables (E&L) studies

Chemical characterization per ISO 10993-18

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)

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

Solutions for neural problems

*Electrical signals in the brain

New technology to improve lives

*Electrical signals in the brain

Genomic data and bioinformatics

*Electrical signals in the brain

Non Clinical Data Management

Comprehensive data collection, validation, analysis and reporting services supporting scientific studies.

GLP Certification

IIBAT operates in compliance with Good Laboratory Practice (GLP) standards, ensuring the quality, integrity, reliability, and traceability of non-clinical laboratory studies. Our GLP-certified facilities support regulatory testing and research programs across multiple scientific disciplines.

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ISO/IEC 17025 Accredited Laboratory

Accredited laboratory services ensuring technical competence, quality assurance, and reliable testing results that meet international standards.

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ISO 9001 Quality Management System

Certified quality management systems ensuring consistent service delivery, operational excellence, and continual improvement in accordance with international standards.

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ISO 14001 Environmental Management System

Certified environmental management systems promoting sustainability, regulatory compliance, resource conservation, and continual environmental improvement.

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ISO 45001 Occupational Health & Safety Management System

Certified occupational health and safety management systems focused on workplace safety, risk prevention, regulatory compliance, and employee well-being.

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ISO 27001 Information Security Management System

Certified information security management systems ensuring data protection, risk management, regulatory compliance, and business continuity.

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Chemistry

State-of-the-art analytical testing services utilizing validated methodologies and advanced instrumentation to ensure accurate characterization, quality assessment, and regulatory compliance.

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Clients & Partnerships

We work with leading global firms, regulatory consultants, academic institutions, and startups. From supporting regulatory filings to conducting complex safety studies, we’ve partnered across the globe to bring compliant, quality-tested products to market.

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Get in touch to discuss how IIBAT can support your product development with scientific rigor and regulatory precision.