Full-stack Safety Assessment for Small Molecules, Biologics & Novel Modalities

Accelerate IND enabling and GLP studies with integrated toxicology, pathology, bioanalysis, computational toxicology, SEND and digital pathology.

Accredited facilities and globally compliant systems supporting regulatory ready preclinical studies

OECD

IBSC

AAALAC

IAEC

ISO

17025

CCSEA

(Govt. of India)

End-to-End Preclinical Safety, Regulatory-Ready

Syngene’s Safety Assessment services provide complete preclinical solutions for evaluating the safety of new drug candidates and products. We support small molecules, biologics, biosimilars, Antibody Drug Conjugates (ADCs), Oligonucleotides, Cell & Gene therapy, vaccines, medical devices, and agrochemicals through in vivo and in vitro testing, advanced pathology, toxicokinetic, bioanalysis, and SEND-compliant data packages, delivering regulatory-ready outputs with speed and scientific rigor. 

Syngene’s computational toxicology unit offers a mechanism-driven approach to safety, integrating algorithms to forecast toxic effects long before they reach animal experiments. Supporting global customers across the US, Europe, and Asia. 100% success rate in obtaining regulatory approvals for clients.

35+

Countries supported

24+

IND/NDA
package submitted globally

100+

Safety Assessment
studies conducted/year

97%

On time data
and report delivery

Exploratory & GLP Toxicology

  • MTD, dose-escalation & short-term studies
  • Repeat-dose toxicology
    (rodent & non-rodent)
  • Chronic, sub-chronic & carcinogenicity studies
  • Reproductive & developmental toxicity (Seg I–III)

Genotoxicity & Safety Pharmacology

  • In Vitro & in vivo genotoxicity (AMES, CA, MNT, micronucleus)
  • Core battery safety pharmacology: CNS (Irwin test), respiratory (plethysmography) & cardiovascular (hERG and dog telemetry)

Specialty & Advanced Toxicology

  • Cytotoxicity
  • Skin irritation/sensitization
  • Local tolerance
  • Dermal, phototoxicity, impurity qualification (ICH M7)
  • Medical device biocompatibility
    (ISO 10993)

PK, TK, Analytical & Bioanalytical Services

  • Bioanalysis (small & large molecules)
  • Method development & validation
  • PK/TK analysis using Phoenix WinNonlin
  • Immunogenicity & neutralizing antibody assays
  • Ligand-binding assays (ELISA, MSD, SPR, cell-based)

Computational Toxicology & Risk Assessment

  • QSAR-based predictive toxicology (DEREK Nexus®, CASE Ultra) 
  • ICH M7 mutagenic impurity assessment
  • PDE & OEL reports
  • Nitrosamine risk assessment (CPCA)
  • Extractables & leachable (PQRI)
  • Nonclinical Overviews and Summaries

SEND Data Services

  • SEND datasets for in-house studies
  • Standalone SEND support for CRO‑generated studies 
  • FDA‑validated (Pinnacle 21) workflows

Committed to ethical animal care

We prioritize the welfare of all research animals through globally compliant practices, dedicated veterinary teams, and enrichment programs. Our approach ensures humane care and adherence to the 3Rs principle while supporting high-quality, reliable safety studies.

Ready to accelerate your therapeutic journey?

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