Services

At IIBAT, we provide comprehensive non-clinical and chemical testing services and regulatory data generation for regulatory submissions to support the safety, efficacy, quality and compliance of pharmaceuticals, industrial chemicals, biologics, medical devices, and agrochemicals. Our expertise ensures that your products meet global regulatory standards standards and requirements, accelerating approvals and market entry.

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)

Clinical solutions

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Biomimicry

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Development

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Data + Technology

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Education

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Clinical solutions

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Chemistry testing

Electrical signals

Biological evaluation

Toxicological assessment