Preclinical CRO Services 

Alliance Regulatory Limited proudly collaborates with Edara Research Foundation (ERF), a leading preclinical CRO based in Hyderabad, India. ERF’s expertise in toxicology, genetic toxicology, ecotoxicology, and physicochemical testing complements ARL’s regulatory and efficacy services, ensuring comprehensive solutions for our customers. For inquiries about ERF’s services, please contact us or visit www.edararesearch.com.

*Toxicology

Acute Oral Toxicity

Acute Dermal Toxicity

Acute Inhalation Toxicity

Acute Dermal Irritation

Acute Eye Irritation

Guinea Pig Maximisation / Buehler Test

Repeat Dose Toxicity - 14, 28, 90 Days - All routes of entry including infusion Toxicity

Maximum Tolerated Dose

Dose Escalation Study

Dose Limiting Toxicity

*Genetic Toxicology

Bacterial Reverse Mutation Test

In vitro Mammalian Chromosome Aberration Test

In vivo Mammalian Erythrocyte Micronucleus Test

In vivo Chromosomal Aberration Assay in Bone Marrow Cells

In vitro Mammalian Cell Micronucleus Test

*Ecotoxicology

Acute Fish Toxicity Study - Labeo Rohita

Daphnia Sp., Acute Immobilization

Alga, Growth Inhibition Test

Acute Toxicity Study In Earthworms

Honeybee Acute Oral Toxicity

Honeybee Acute Contact Toxicity

Avian Oral Toxicity (JQ)

*Method Validation and Dose Verification Analysis

Method Validation and Dose Formulation Analysis

Method Validation and AI Content analysis of aerosols for Inhalation Study

*Five Batch Analysis - Technical equivalence

Pre-Screening (Using Suitable Technique) - Significant impurities ≥0.1% w/w and boderline impurities 0.1% > x ≥ 0.06%. Scanning of 5 batches using suitable techniques

5 Batch Analysis - Mains

Method Development, Validation, Analysis. Identification and Characterizations of actives and impurities. 3D chromatogram.

*Five Batch Analysis

5 Batch Analysis (Quantification of Purity amd Impurity)

Method Development, Validation, Analysis. Identification and Characterizations of actives and impurities

*Physical Chemical Properties

A.I. Content

A.I. Content with method validation - GLP CoA

Accelerated storage stability – including relevant physicochemical parameters and a.i content

Accelerated storage stability – including relevant physicochemical parameters and a.i content combined with corrosion characteristics

Acidity/Alkalinity

Analytical Method Development

Analytical Method Validation

Appearance (Physical State, Aspect, Color Odor)

Attrition resistance

Auto ignition temperature (Liq and Gas)

Boiling point / Boiling Range

Certificate of physico-chemical

Certificate of physico-chemical (GLP CoA) (AI content) including method validation - 5 batch

Certified Limits

Corrosion Characteristics

Density: Bulk / Tap / Relative

Determination of container compatibility (reactivity with packing material)

Dilution Stability of aqueous solutions

Dispersibility of water dispersible granules

Dispersion Stability of suspo-emulsions

Dissociation Constant - Spectrophotometric Method

Dissociation constant-Titration

Dissolution degree and solution stability

Dissolution rate of water soluble bags

Dustiness of granular products – revised method

Emulsion characteristics and re-emulsification properties (Emulsion Stability)

Enforcement Analytical Method

Evaluation of physical compatibility of pesticides

Explodability

Flammability

Flash point

Flowability (Flowability of granular formulations after accelerated storage under pressure – revised method)

Freezing point

Hydrolysis as function of pH (Tier 1)

Hydrolysis as function of pH (Tier 2)

LOD (Loss on Heating)

Low Temperature Stability

Material insoluble in acetone

Melting / Freezing Temperature

Melting point / Melting Range

Miscibility (Organic Solvent)

Moisture content / Water Content

Oxidation / Reduction - Chemical incompatibility

Oxidizing properties

Packaging Stability

Particle Size: Nominal Size Range Granules - Dry Seive

Particle Size: Nominal Size Range Granules - Laser Particle Size (Outsourced)

Particle Size: Seive Analysis - Dry Seive - Dusts

Particle Size: Size Distribution - Powder

Particle Size: Solids

Particle Size: Water Dispersible Products (Wet Seive Test)

Partition coefficient (HPLC) - log P ow value (see below for definitions) falls within the range - 2 to 4 and the latter within the range 0 to 6.

Partition coefficient (shake flask method) - log P ow value (see below for definitions) falls within the range - 2 to 4 and the latter within the range 0 to 6.

Persistant foam

pH

Photolysis: Direct Photolysis - Phototransformation of Chemicals in Water ( Non radio active Isotopes) - Tier 1

Photolysis: Direct Photolysis - Phototransformation of Chemicals in Water ( Non radio active Isotopes) - Tier 2

Pourability

Reaction with packaging Material

Ready Biodegradability

Relative Self Ignition for Solid

Soil – Carbon transformation test (Outsourced)

Soil – Nitrogen transformation test (Outsourced)

Solubility in organic solvents (Acetone /Methanol) (up to 5 solvents)

Spectra (IR)

Spectra (MS) (nGLP)

Spectra (NMR) (nGLP)

Spectra (UV-VIS)

Spontaneity of dispersion of suspension concentrates

Stability to normal and elevated temperatures, metals and metal ions

Storage stability (1 years with 7 analysis)

Storage stability (2 years with 7 analysis)

Sulphated ash

Surface tension of Aq. Solution

Suspensibility (Suspensibility of formulations forming suspensions on dilution with water – revised method)

Thermal Stability and Stability in Air / Decomposition temperature

UV Vis Absorption

Vapor pressure (Effusion Method - Isothermal Thermogravimetry)

Viscosity

Volatility

Water Solubility: Shake Flask/Column Elution Method

Wettabilty

• Connect with us to enhance your regulatory process with ERF’s expertise and ARL’s dossier monitoring support.