Our Core Capabilities

The studies listed could be utilized to evaluate tolerability, guide formulation decisions, and pre-plan and design GLP studies. 

Capabilities: 

• MTD (Maximum Tolerated Dose) studies
• Dose escalation and range-finding
• Repeat-dose studies (short-term)
• Toxicokinetic studies 

We offer computational and model-based evaluations to support impurity profiling, material safety, and predictive toxicology, enabling early identification of potential risks and efficient resource allocation.

Capabilities: 

• Nitrosamine (NDSRI) risk assessment
• ICH M7 impurity qualification
• Extractables and leachables (E&L) analysis
• Permitted Daily Exposure (PDE) and Occupational Exposure Limit (OEL) setting

Tools and Platforms:

• DEREK Nexus®
• CASE Ultra
• OECD QSAR

Our preliminary in vitro and in vivo safety testing suite offers predictive insight into genotoxic and cellular responses, helping clients screen compounds in line with regulatory expectations early in development. 

Capabilities: 

• AMES (bacterial reverse mutation)
• Mini AMES
• Chromosomal aberration (in vitro and in vivo)
• Micronucleus assay (in vitro and in vivo)
• Mammalian cell gene mutation
• Cytotoxicity
• Skin absorption, irritation, and sensitization
• Eye irritation
• In vitro and in vivo phototoxicity 

For later-stage development, TCGLS conducts full-spectrum general toxicology studies, including repeated dose and chronic evaluations to support global regulatory submissions. 

Capabilities:

• Acute toxicity (single dose / six-pack)
• Sub-acute toxicity studies (Repeat dose: 7, 14, 21, 28, 42 days)
• Sub-chronic toxicity studies (Repeat dose for 90-days)
• Chronic toxicity studies (Repeat dose for 120 and 180-day) 
• Local tolerance and irritation studies 
• Skin sensitization: LLNA, GPMT, Buehler assays
• Reproductive toxicity (Segment I–III)
• Carcinogenicity studies
• Neurotoxicity 
• Endocrine disruption: 
  
  • Hershberger assay
  • Uterotrophic assay

   

Accurate measurement of test article concentration and systemic exposure is central to the integrity of every study result. Our GLP lab ecosystem enables integrated support across all tox workflows.  

Analytical Services: 

• Test item characterization
• Physical–chemical analysis
• Method development and validation
• Stability, homogeneity, and dose confirmation 

Bioanalytical Services: 

• LC-MS/MS and ELISA-based bioanalysis
• Method validation across species and matrices
• Toxicokinetic profiling (Phoenix WinNonlin®)
• Immunogenicity and neutralizing antibody assays 

To evaluate pharmacodynamic safety, TCGLS offers focused in vivo studies that assess the potential effects of compounds on vital systems. 

Capabilities: 

• CNS: Functional observation battery (FOB) & modified Irwin test
• Cardiovascular: hERG assay, telemetry 
• Respiratory: Whole-body plethysmography
• Gastrointestinal: Functional safety testing 

We offer a wide range of validated biological systems to support absorption, distribution, metabolism, and safety testing. 

Available Systems: 

• Human and animal hepatocytes, microsomes, S9, cytosol
• Intestinal S9, blood, plasma, tissues (brain, kidney, spleen)
• Cell lines: Caco-2, MDCK, HEK-293, CHO-K1
• Vesicles: MRP2, BSEP, BCRP
• Buffers and biorelevant media (SGF, FaSSIF, FeSSIF, etc.) 

We offer validated rodent and higher species models for all in vivo toxicology studies. All models have been tested using standard reference compounds to ensure data reliability. 

• Rat, mouse, rabbit, guinea pig, minipig, dog, farm pig, sheep, goat, cattle
• Flexible sourcing from certified domestic and international vendors
• Robust process governance, scientific transparency, and operational agility 

In collaboration with our trusted partner, we offer efficacy, safety, and performance evaluations of medical devices in non-rodent species such as rabbits, swine (including minipigs and conventional pigs), dogs, and sheep for regulatory submissions. We also provide ISO 10993-compliant biocompatibility studies for a wide variety of medical devices. 

Testing Capabilities 

• Cardiovascular Devices 
  
  • Coronary Vascular Devices
  • CRM Devices
  • Electrophysiological Devices
  • Peripheral Vascular Devices
  • Prosthetic Devices
  • Active Implantable Devices
  • Inert Implantable Devices

• Other Devices 
  
  • Gastrointestinal Devices
  • Wound Healing Matrices/Devices
  • Ocular Implant Devices
  • Genitourinary Devices
  • Orthopaedic Devices
  • Dental Devices
  • Ocular Implant Devices

At TCG Lifesciences, we specialize in providing GLP-compliant toxicology and safety pharmacology studies tailored for small molecule drug candidates. Our IND-enabling packages are designed to meet global regulatory requirements (FDA, EMA, ICH) and support a seamless transition into first-in-human clinical trials.

Our IND-Enabling Study Package Includes:

• General Toxicology (GLP)
  • Single-dose (acute) toxicity studies
  • Repeat-dose toxicity studies (7, 14, 28, and 90-day) in rodents and non-rodents (via partners)
  • Dose Range Finding (DRF) studies
  • Recovery group assessments
  • Clinical observations, body weight, and food consumption monitoring
  • Clinical pathology evaluations (hematology, clinical chemistry, urinalysis)
  • Gross necropsy, organ weights, and comprehensive histopathology
• Toxicokinetic (TK) & Systemic Exposure Analysis
  • Parallel TK sampling during repeat-dose studies
  • Bioanalytical method development and LC-MS/MS sample analysis
  • Exposure-response assessment to determine NOAEL
• Safety Pharmacology (ICH S7A Core Battery)
  • Central Nervous System (CNS): Functional Observation Battery (FOB) / Modified Irwin Test
  • Cardiovascular: ECG, heart rate, and blood pressure monitoring (via telemetry in non-rodents through partners)
  • Respiratory: Respiratory rate, tidal volume, and minute volume (via whole-body plethysmography)
• Genetic Toxicology
  • Bacterial reverse mutation assay (Ames test)
  • In vitro mammalian chromosomal aberration test
  • In vivo micronucleus test in rodents
• Additional IND-Enabling Support
  • Maximum Tolerated Dose (MTD) studies
  • Species selection guidance and study design consultation
  • Access to reproductive and developmental toxicology studies (as required)
  • Regulatory-compliant reporting suitable for IND/CTA submissions

We can customize the list as per collaborator requirements.