Safety Assessment (Toxicology Services)

• Bioanalytical services to support GLP IND enabling study package for FDA, EMEA, MHRA and other global regulatory submissions, and also for other studies requiring analytical support.
• Excellent capability to develop and validate bioanalytical methods using state-of-the-art LC-MS/MS & HPLC instrumentation and achieve sensitivity up to picogram levels
• Developing fit-for-purpose methods for non-GLP bioanalysis
• Sample processing using precipitation, liquid-liquid extractions and solid-phase extractions
• Capability for derivatization approaches (e.g. for poorly ionizable compounds) including method development and validation
• Quantification of analyte / metabolite(s) in biological matrices such as plasma, serum and blood samples in compliance with latest regulatory requirements of USFDA, EMEA, etc.,
• Experience with developing methods for other matrices such as urine, feces, CSF, bile and various tissue homogenates
• GLP bioanalysis to support preclinical bioequivalence studies
• Experience with specialized formulations such as liposomes
• Equipped with Watson LIMS – 21 CFR Part 11 compliant Data Management System for data

• Capability for method development and validation to comply with GLP requirements
• Bioanalytical method feasibility, method development and validation including method transfer using ELISA methods
• Validation using commercially-available ELISA kits
• Capability for peptide and protein bioanalysis by ELISA methods
• Preclinical (non-GLP and GLP studies)
• Immunogenicity/antigen-antibody assays including neutralizing antibody assays
• Capability for biomarker assays
• Biomarker identification and quantification

• Eurofins Advinus is engaged in integrated drug development starting from CMC, DMPK, Analytical to Safety Assessment including cGMP material for supporting early clinical development up to Phase II clinical trials.
• While predominantly ICH Guidance documents are followed for all toxicology studies to comply with global preclinical requirement, where applicable, detailed OECD and others guidelines, would be followed to provide more specifics to study details.
• Laboratories are fully equipped with the latest equipment which are validated, regularly calibrated and manned by adequately trained, experienced staff.

• Over two decades of experience conducting carcinogenicity studies in accordance with OECD/USFDA guidelines
• Highly skilled study directors with 15-20 years of experience handling carcinogenicity studies in rodents
• Eurofins Advinus has the largest animal vivarium used for conducting carcinogenicity studies in India
• Completed 65+ studies with extensive historical control data both for Agro and Pharma compounds
• Experience in conducting carcinogenicity studies using data analyzed and protocols approved by the Carcinogenicity Assessment Committee (CAC) of USFDA
• Survival of animals included in the carcinogenicity studies is > 80 %
• Data successfully submitted to regulatory agencies around the globe
• Recently successfully completed and submitted report for a 2 year rat carcinogenicity with BID dosing for a pharma compound
• Capability to compile study data files in accordance to FDA approved “Standard for Exchange of Non-Clinical Data (SEND)” format for regulatory submission
• Peer review pathology services by independent overseas ‘Board Certified Pathologists’ is offered

• Screening models for carcinogenicity assay using Tg rasH2 mice
• One of the few contract research labs world-wide to offer carcinogenicity study in Tg rasH2 transgenic mice
• Experience in conducting the study using data analyzed and protocols approved by the carcinogenicity assessment committee (CAC) of USFDA
• Survivability of 100% achieved in the vehicle control group in 6-month carcinogenicity study and data successfully submitted to USFDA
• Capability to compile study data files in accordance to USFDA approved “Standard for Exchange of Non-Clinical Data (SEND)” format for regulatory submission

• Eurofins Advinus has excellent knowledge and expertise in assessing toxicity of impurity(ies) of pharmaceuticals in rodents as per ICH Q3A and ICH Q3B guidelines.
• Capability to test APIs with more than 1 up to 10 impurities.
• Eurofins Advinus has successfully designed and conducted more than 25 impurity qualification studies in rodents which have been accepted by various regulatory authorities around the globe including USFDA.

We have an outstanding team of pathologists with over 30 years of pathology services across both pharmaceuticals and agrochemicals. Our work has been successfully peer-reviewed multiple times by board certified pathologists from US, Europe and Japan. Included in our team is Prof. Vijayasarthi, an IATP fellow and an expert pathologist with 35years of experience.

We now offer Stand Alone Pathology Services for the in-life phase of the studies conducted elsewhere. The formalin preserved/ wet tissues or paraffin embedded tissue blocks supplied by the client can be processed at our facility, the tissue slides evaluated and a comprehensive pathology report generated for submission through online data capture system.

• With experts in intravenous infusion through tail vein in rats, Eurofins Advinus has conducted toxicological studies for evaluating parenteral drug formulations
• Capability is also available for continuous infusion up to 2 hours in rats. Eurofins Advinus has successfully completed 5 cycle IV infusion study and also 28-days repeat IV infusion study in rats to assess toxic effects of parenteral drug formulations

• Eurofins Advinus has more than a decade of experience in conducting LLNA studies in mice which has largely superseded the guinea pig maximization test and the Buehler test.
• Well-trained and experienced study directors are available to conduct LLNA studies in mice according to OECD guideline No. 429 to provide quantitative data suitable for dose response assessment

• Current regulatory environment for pediatric drugs is driving juvenile toxicology studies which are useful in addressing specific concern in pediatric trials.
• Eurofins Advinus has expertise in conducting juvenile rat toxicology studies and the reports have been submitted to various regulatory agencies including USFDA.

Eurofins Advinus has broadened its scope of services through the introduction of in vitro Skin Irritation (OECD 439) and in vitro Skin Corrosion tests (OECD 431). These in vitro tests will be assessed using the Human 3-Dimensional EpiSkin® test kit. The tests have been validated in our laboratory by employing the OECD Guideline mandated proficiency substances. The in vitro EpiSkin® tests are routinely used for cosmetic raw materials and cosmetic formulations. In addition, current OECD guidelines for in vivo (whole animal) skin irritation tests mandate that prior to testing in animals all agrochemical and industrial (REACH) chemicals must be evaluated by employing in vitro tests. These tests are offered both under GLP for regulatory submission and also under non-GLP for screening in the research mode. Both in vitro EpiSkin® tests can be taken up in one week following supply of the compound and results can be provided with a week.

• A decade long experience in data capture and protection: Provantis^® is being used in all Toxicology/Clinical Pathology/Pathology areas.
• Computers networked with large number of workstations to enable on-line transfer of data
• Digital Pathology services
  • Efficient and validated in-house software packages are used for statistical analysis and interpretation of data
  • Historical data acquired over the years are available for clinical signs, body weight, feed intake, hematology and clinical chemistry, histopathology and tumor incidence. In addition, the historical data available for all types of reproduction studies, including fertility, pre and/ or postnatal studies.

• Drugs that are shorter half-life or rapid clearance or limited solubility and based on its clinical regimen, twice (BID) daily administration is generally preferred to maximize/achieve desired systemic exposure in nonclinical studies.
• Eurofins Advinus has the experience and capabilities of conducting 28-day and longer duration term toxicology studies with more than once daily administration, including carcinogenicity/reproduction studies in Rodents.
• Conducted 25+ repeated dose, reproduction and carcinogenicity studies, including carcinogenicity study in rasH2 Transgenic mice