At Aurigene, we specialize in providing a broad spectrum of pre-clinical toxicology studies with a proven track record, tailored to meet the diverse needs of our clients. Our services include single-dose and repeat-dose toxicity, reproductive toxicity, in vitro and in vivo genetic toxicity, core safety pharmacology battery and long-term toxicity studies. Our clients have successfully filed IND/NDA/ANDA/505(b)(2) applications with regulatory authorities including the US FDA, MHRA, EMA, and DCGI.
Over the last 20+ years, we have conducted more than 1,000 exploratory toxicology studies, empowering early discovery efforts and facilitating informed candidate selection. Established in 2002, Aurigene Toxicology Services has been recognized for its commitment to quality, achieving GLP certification by the Netherlands in 2003 and National GLP Compliance Monitoring Authority of India (NGCMA) since 2004. The Test Facility is also fully accredited by the AAALAC for standard lab animal care since 2021.
Our mission is to help driving innovation and enable the seamless progression of drug discovery and development with reliability, precision, and regulatory compliance.
The team is proficient with a wide range of administration routes including oral, intraperitoneal, intramuscular, subcutaneous, intradermal, inhalational, intravitreal injection, and intricate intravenous infusions. We ensure timely and accurate communication across time zones by optimizing workflows, processes, and communication technologies.
The following section outlines the various general, reproduction and genetic toxicity studies conducted by our team. These studies are essential for evaluating the safety and efficacy of new drugs and compounds, ensuring they meet regulatory standards and are safe for use.
Why Choose Aurigene Pharmaceutical Services?
Proven experience with submissions to the US FDA, MHRA and DCGI
Team of highly qualified and experienced scientists
Capacity to handle more than 1000 rodents simultaneously
State-of-the-art infrastructure
Support for both standalone and integrated services for IND filings
Comprehensive biology capabilities for Integrated Drug Discovery
GLP certified and AAALAC accredited toxicology laboratory
Other Services
- Carcinogenicity Studies and Services
- DMPK Studies
- General Toxicology Services
- Genetic Toxicology Studies and Services
- In vitro Biology and Assay Services
Carcinogenicity Studies and Services
DMPK Studies
General Toxicology Services
Genetic Toxicology Studies and Services
In vitro Biology and Assay Services
In vitro Genotoxicity Testing Services
In vivo Pharmacology Studies and Services
Reproductive Toxicity Studies
Microbiology Testing Services
Safety Pharmacology Studies and Services
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Hyderabad R and D Center
Bangalore R and D Center
Toxicology Studies
Connect with our scientific experts for your drug discovery, development, and manufacturing needs
We understand that clear communication is essential to successful collaborations, and that's why we have a dedicated team that is always ready to help you. Whether you have questions about our services, want to discuss a potential partnership, or simply want to learn more about our company, we're here to help.
Our team of experts is dedicated to providing personalised solutions tailored to your unique needs. So, please don't hesitate to reach out to us. We look forward to hearing from you and helping you achieve your business goals.
Learning Resources
JUNE 28, 2022
Neoantigen Specific T cells For Cancer Immunotherapy
An effective anti-tumor immune response in human is marked by presence of T cells reactive against neoantigens. Neoantigens are HLA-bound unique peptides arise from tumor-specific somatic mutations. Neoantigens are highly immunogenic because they are not present in normal tissues and hence bypass central thymic tolerance. The success of immune checkpoint blockade...
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Accelerating Drug Discovery Through Innovative Partnerships
Genomics plays a vital role in identifying which gene is associated with a specific disease. A gene called CNOT1 is for example known for it's effect on brain development and for impairing memory and learning. Despite the great promise genomics provides in understanding the disease, genes are not the best drug targets....
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Systematic formulation design - shorten development cost & time
Project Challenge: Existing formulation (lower strength - 50 mg) was manufactured using direct compression process. This formulation posed poor powder flow and content uniformity issues during scale-up. Development of new strength 150 mg without any process issues was a challenge. Solution design: Preliminary pre-formulation, stress study and PSD impact assessmen...
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August 28, 2020
An efficient and convenient protocol for the synthesis of tetracyclic isoindolo[1,2-a]quinazoline derivatives
A convenient and one-pot synthesis of tetracyclic isoindolo [1,2-a]quinazoline derivatives via Lewis acid mediated sequential C–N bond formation reactions is reported. This protocol provides a simple and rapid strategy for the synthesis of 12-benzylidene-10,12-dihydroisoindolo[1,2-b]quinazoline derivatives. However, a variety of tetracyclo indole fused quinazol...
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January 31, 2025
Development and assessment of a Bcs class II - SGLT2 (Sodium Glucose Cotransporter 2) inhibitor drug in the form of solid lipid Nanoparticles by selecting different lipids, co-surfactants, and manufacturing techniques
Drug Delivery System (DDS) has been used successfully in the past few decades to cure illnesses and enhance health because of its improved systemic circulation and ability to regulate the drug's pharmacological action. As pharmacology and pharmacokinetics advanced, the idea of controlled release emerged, demonstrating the significance of drug release in assessing...
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January 31, 2025
Development of novel paullone-based PROTACs as anticancer agents
Proteolysis-targeting chimera (PROTACs) represents a promising modality that has gained significant attention for cancer treatment. Using PROTAC technology, we synthesized novel structurally modified paullone-based PROTACs using Cereblon (CRBN) and Von Hippel–Lindau (VHL) E3 ligands....
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March 13, 2025
Development and verification of RP-HPLC method for the quantitative determination of Decitabine in tablet dosage formulation
Decitabine is an anti-cancer chemotherapy drug. This article describes method development and method verification of Assay of Decitabine in tablet formulation. A new, precise, rapid, accurate RP-HPLC method has been developed for the estimation of Decitabine in pharmaceutical tablets dosage form. After optimization the good chromatographic separation was achieved...
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Frequently asked questions
What are genetic toxicology studies, and why are they important?
Genetic toxicology studies are specialized safety studies designed to evaluate whether a drug candidate can cause DNA damage, gene mutations, or chromosomal abnormalities. These studies form a key part of nonclinical safety assessment and are required under global regulatory guidelines before clinical trials. Genetic toxicology testing helps identify mutagenic or clastogenic risks that may lead to cancer or heritable genetic effects.
Through structured genetic toxicology services, sponsors can detect genotoxic liabilities early, refine chemical design, and reduce long-term development risk. Well-executed genetic toxicology studies provide critical data for regulatory submissions and help ensure that only molecules with an acceptable genetic safety profile move forward.
How do genetic toxicology studies support drug development?
Genetic toxicology studies directly support drug development by identifying genotoxic risks during early and preclinical stages. Early genetic toxicology testing allows development teams to optimize lead compounds, adjust dose strategies, or discontinue high-risk candidates before significant investment. This reduces costly late-stage failures and improves overall portfolio quality.
Comprehensive genetic toxicology services also generate the regulatory data package required for IND submissions and global filings. By integrating genetic toxicology studies into the broader safety strategy, sponsors can strengthen their risk assessment and accelerate decision-making with confidence.
What sets Aurigene Pharmaceutical Services apart in genetic toxicology testing?
Aurigene Pharmaceutical Services is recognized among reliable genetic toxicology testing companies for its integrated scientific expertise and regulatory-focused execution. We provide end-to-end genetic toxicology services, including study design, assay selection, execution, data interpretation, and regulatory-ready reporting.
Our teams follow global guidance for genetic toxicology testing and ensure consistent documentation, quality controls, and traceability. By combining technical depth with structured project management, Aurigene delivers genetic toxicology studies that are scientifically robust, compliant, and aligned with sponsor timelines.
What species or models are used in your genetic toxicology studies?
Genetic toxicology studies typically use a combination of in vitro and in vivo models, depending on regulatory requirements and molecule characteristics. In vitro genetic toxicology testing commonly includes bacterial reverse mutation assays (Ames test) and mammalian cell-based chromosomal damage or gene mutation assays.
For in vivo assessment, rodent models are often used to evaluate micronucleus formation or chromosomal damage in bone marrow or peripheral blood. The selection of models is based on global regulatory expectations and the specific development pathway. Through well-designed genetic toxicology services, Aurigene ensures that the chosen models provide meaningful, compliant, and decision-enabling safety data.
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