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Safety Assessment Services
Pharmacology, and Safety Services

Safety Assessment Services

we partner with pharmaceutical and biotech companies to streamline the path from discovery to IND submission through our comprehensive GLP and non-GLP toxicology services. With GLP-certified, AAALAC-accredited facilities, a team of seasoned scientists, and advanced technologies, we deliver high-quality safety assessment data that meets the most rigorous global regulatory standards.

Our deep regulatory expertise and commitment to data integrity ensure smooth study execution-empowering you with the confidence and clarity to make informed decisions about your drug candidates’ safety and efficacy.

Toxicology Studies

Our Non-GLP & GLP Toxicology Studies services are designed to evaluate safety profiles in diverse models with unparalleled precision.

Single and Multiple Dose Toxicity Studies
Assess potential adverse effects in rodent and non-rodent models.

Local Toxicity Studies
Ensure site-specific tolerance at the drug administration site.

Toxicokinetic Studies
Deliver complete insights into absorption, distribution, metabolism, and excretion (ADME) of drugs, particularly at doses that may cause toxicity.
Safety Pharmacology
Through advanced methodologies, we analyze the impact of drug candidates on key physiological systems.
 

Our Non-GLP studies support early-phase research by identifying potential risks, while GLP-compliant studies ensure regulatory adherence for submission and approval. This dual approach enables both exploratory assessments and comprehensive safety evaluations.

  • Key systems assessed
  • Central Nervous System
  • Cardiovascular System
  • Respiratory System

Genotoxicity Studies

We assess the genetic safety of compounds using industry-standard tests. Our Non-GLP studies provide early risk identification, while GLP-compliant studies meet regulatory requirements for submission.

Testing Methods
  • Ames Test – Detects mutagenic potential in bacteria.
  • Chromosomal Aberration Test – Identifies structural changes in chromosomes.
  • Micronucleus Test – Evaluates chromosome damage in cells.
Immunogenicity Studies

Immunogenicity studies assess potential immune responses to drug candidates, ensuring both safety and efficacy for clinical applications. Our Non-GLP studies support early-phase risk assessment, while GLP-compliant studies provide validated data for regulatory submissions.

Reproductive Toxicity Studies

We evaluate the effects of compounds on mammalian reproduction and embryonic development across all study stages. Our Non-GLP studies aid early risk identification, while GLP-compliant studies ensure regulatory adherence for comprehensive safety assessment.
Carcinogenicity Studies

Carcinogenicity studies involve observing test animals for a major portion of their life span (a maximum of two years for rats) for the development of neoplastic lesions during or after exposure to drugs with an appropriate administration route. We collect extensive data, especially histopathology data, to evaluate tumor related parameters.