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Aragen Biosafety Solutions is a leading provider of GLP-compliant nonclinical safety, toxicology, and bioanalytical services supporting pharmaceuticals, biologics, medical devices, chemicals, and agrochemical products. We help organizations generate high-quality data for regulatory submissions, enabling faster and more confident decision-making from early development through approval.

Comprehensive Scientific Solutions

Nonclinical Safety & Toxicology Studies

We provide a full range of toxicology studies designed to evaluate the safety profile of drugs and chemicals, including general toxicology, genetic toxicology, safety pharmacology, reproductive and developmental toxicity, carcinogenicity, and inhalation studies.

Our studies are designed to meet global regulatory requirements, supporting IND, NDA, and international submissions.

Analytical & Bioanalytical Services

Our advanced laboratories deliver analytical chemistry and bioanalytical testing services, including method development, validation, and sample analysis. We support both preclinical and clinical programs with accurate, reproducible, and compliant data.

IND-Enabling & Regulatory Support

We specialize in IND-enabling studies and regulatory strategies, helping clients navigate complex global requirements. Our team ensures your data packages are submission-ready and aligned with regulatory expectations.

Environmental & Agrochemical Testing

We offer specialized services for environmental toxicology and agrochemical safety, including endocrine disruptor screening, metabolism studies, and environmental fate assessments such as soil degradation.

Applied Safety Solutions Across Industries

Aragen Biosafety Solutions delivers applied safety solutions by extending its proven toxicology and analytical expertise to address product-specific safety challenges across regulated sectors. These solutions support real-world decision-making where rigorous, science-based safety evaluation is critical for regulatory compliance and market readiness.

Our capabilities span:

  • Industrial & Specialty Chemical Risk Assessment – Hazard identification and risk evaluation to support regulatory submissions and compliance 
  • Medical Device Biological Safety Evaluation – Toxicological risk assessment and supporting studies addressing biological safety requirements 
  • Nutraceutical Safety Assessment – Nonclinical testing to substantiate product safety and regulatory readiness
  • Veterinary Nonclinical Safety Studies – Integrated safety evaluation supporting animal health product development through systemic toxicity, safety pharmacology, and reproductive assessment

Advanced Test Facility & Quality Systems

Our state-of-the-art facility operates under strict GLP compliance, supported by robust quality systems to ensure:

  • Data integrity and traceability
  • Consistent, high-quality results
  • Global regulatory acceptance

Why Aragen Biosafety Solutions

At Aragen Biosafety Solutions, we combine scientific expertise, global compliance, and a strong quality-driven culture to deliver reliable safety assessment solutions across industries.

Proven Experience & Scale

With over 25 years of expertise and more than 18,000 GLP studies completed, we bring deep domain knowledge across pharmaceuticals, biologics, agrochemicals, and specialty chemicals.

Global Quality & Accredited Excellence

Our facilities are OECD GLP-certified and AAALAC accredited, ensuring studies meet stringent international regulatory standards and are accepted globally.

Expert Scientific Team

Our multidisciplinary team includes board-certified toxicologists, pathologists, study directors, and analysts, delivering high-quality, decision-ready data across every stage of development.

Integrated End-to-End Solutions

As part of Aragen Life Sciences, we offer seamless, integrated services from discovery through preclinical and clinical development—reducing timelines, eliminating redundancies, and accelerating speed to market.

Customer-Centric Approach

We work as an extension of your team—offering flexible, collaborative, and transparent engagement models with a strong focus on meeting timelines and exceeding expectations.

Commitment to Integrity, Innovation & Compliance

Guided by strong core values—integrity, teamwork, innovation, and safety—we ensure every study is conducted with the highest standards of ethics, scientific rigor, and regulatory compliance.

Reliable Data for Confident Decisions

Our focus on high-quality, accurate data generation supports both regulatory submissions and internal decision-making, helping you move forward with confidence at every stage of development.

Your Partner in Drug Development & Safety Assessment

At Aragen Biosafety Solutions, we deliver reliable safety data, regulatory expertise, and scientific excellence to help you reduce risk, accelerate development timelines, and achieve successful approvals in global markets.

Looking for a trusted partner in toxicology studies, bioanalysis, or regulatory support?
Connect with our experts to discuss your project requirements.