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Biosafety

Aragen Biosafety Solutions (ABS), previously known as Intox Pvt Ltd, is a leading, multi-segment, multi-vertical provider of GLP-compliant nonclinical safety, toxicology, and bioanalytical services. With over 28 years of experience, ABS is an OECD GLP-certified and AAALAC-accredited organization specializing in non-clinical safety assessment.

Located on a modern, 5-acre campus in Pune, India, ABS offers comprehensive analytical, bioanalytical, and toxicological support for pharmaceuticals, biologics, medical devices, chemicals, and agrochemical products.

Its team of highly experienced professionals—including board-certified toxicologists (DABTs), pathologists (ACVP and DIBTP), study directors, veterinarians, analysts, and quality assurance experts—ensures the generation of high-quality data. To date, ABS has successfully conducted more than 19,000 GLP studies across diverse industries.

Comprehensive Scientific Solutions

  • Nonclinical Safety & Toxicology Studies
  • Analytical & Bioanalytical Services
  • IND-Enabling & Regulatory Support
  • Environmental & Agrochemical Testing
  • Applied Safety Solutions Across Industries
  • Clinical Bioanalysis

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
  • Clinical Bioanalysis – Comprehensive support from method development and validation through clinical sample analysis, enabling pharmacokinetic studies, immunogenicity assessments, biomarker evaluation, and therapeutic drug monitoring.

Aragen BioSafety Solutions: Trusted Global Partner in Preclinical Safety

Globally Compliant
  • OECD GLP Certified
  • AAALAC Accredited
  • CDSCO Approved
Service Segments
  • Pharma & Biopharma
  • Drug Discovery
  • Generics
  • Biosimilars
  • Nutraceuticals
  • Herbals
  • Agrochemicals
  • Industrial Chemicals
Services Verticals
  • Preclinical Safety & Toxicology
  • Discovery – Exploratory & IND-Enabling Studies
  • Analytical
  • PK & Bioanalysis
Knowledge Engines
  • Board-Certified Toxicologists & Pathologists
  • Industry-Recognised Scientific Leads
  • Experienced Team
Project Management
  • Milestone-Driven Planning & Tracking
  • Transparent Client Updates – Total Study Visibility
  • Defined Phase Deliverables
  • Proactive Risk & Deviation Communication

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.

FAQs

Aragen BioSafety Solutions is an OECD GLP-certified, AAALAC-accredited nonclinical safety and toxicology CRO with over 28 years of experience. With more than 19,000 GLP studies completed, the team includes board-certified toxicologists (DABTs), pathologists, study directors, and QA specialists — delivering end-to-end preclinical safety programs from a single, fully integrated facility in Pune, India.

Aragen BioSafety Solutions provides GLP-compliant services across three core areas: Toxicology: General, genetic, safety pharmacology, reproductive, inhalation, and carcinogenicity studies Bioanalytical & Analytical: Bioanalysis, bioassay, analytical chemistry, and clinical bioanalysis IND & Regulatory Support: Full nonclinical safety programs and dossier preparation aligned to FDA, EMA, ICH, and OECD guidelines\

Yes. Aragen BioSafety Solutions is OECD GLP-certified and AAALAC-accredited, meaning study data is accepted by the US FDA, USEPA, EMA, and other international regulatory agencies. Sponsors pursuing multi-regional approvals can rely on a single study package — eliminating the need to repeat studies for different regulatory jurisdictions.

Yes. Aragen BioSafety Solutions delivers end-to-end IND-enabling programs integrating toxicology, ADME, pharmacology, bioanalysis, and regulatory dossier support under one roof. Study designs are tailored to your molecule type — small molecule, biologic, or medical device — and aligned to FDA, EMA, and ICH requirements. Contact the team to discuss your program timeline and study design.

Yes. Intox Pvt Ltd has been rebranded as Aragen BioSafety Solutions Pvt Ltd, following its acquisition by Aragen Life Sciences. All GLP certifications, AAALAC accreditation, quality systems, scientific teams, and ongoing studies remain fully intact. Existing clients can continue their programs without any disruption, now with access to Aragen's broader integrated drug discovery and development capabilities

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