IND Enabling Studies / Studies for NCEs

Adopting an integrated strategy, we provide comprehensive safety assessments essential for Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and New Drug Application (NDA) submissions, as an integral component of our advanced drug development methodology.We hold registration under the US FDA with FEI number 3017185612 and the D&B DUNs Number 87094706. Our team of seasoned scientists, originating from esteemed institutions, brings a wealth of expertise to the drug development process. We provide high-quality scientific guidance throughout the drug development cycle, ensuring seamless support from initial stages to project completion. With extensive experience handling IND molecules, we offer personalized assistance in developing tailored methodologies based on various routes of administration, aligning with clinical and regulatory requirements.

Formulation Analysis / Bioanalysis
  • Bioanalytical Method Development and Validation in rat/dog plasma using LC-MS/MS
  • Bioanalysis (Sample analysis) using LC-MS/MS
  • Dose Formulation Analysis – HPLC from various in vivo and in vitro toxicity studies
  • Analytical Method Development and Validation for Dose formulation analysis and Stability.
Genetic Toxicology
  • In Vivo Mouse Micronucleus Test
  • AMES Test
  • In Vitro Chromosomal Aberration Assay
In Vitro DMPK
  • Blood to Plasma Ratio
  • Plasma Protein Binding
  • Hepatocyte Stability
  • Microsomal Binding
  • Cytochrome P450 Inhibition
  • Microsomal Stability
  • Metabolism Assay
  • Permeability and p-gp; Caco-2 based assessment
Multi Species Pharmacokinetics
  • Pharmacokinetics (PK) in Dog*
  • Pharmacokinetics (PK) In Rat
  • Pharmacokinetics (PK) In Mice
Safety Pharmacology
  • Neurological Safety Study - Modified Irwin Test in Rats (FOB)
  • Respiratory Safety Study - Whole Body Plethysmography in rat*
  • Cardiovascular safety study - Telemetry in Dogs*
  • hERG Assay*
Safety Toxicology Studies
  • 28 Day Repeated Dose Toxicity Study in Dog with Recovery and TK*
  • MTD - 14 Day Repeated Dose Toxicity Study in Dog with TK*
  • Skin Sensitization Study – Guinea pig
  • Single Dose Oral Toxicity Study in Dog*
  • Single Dose Oral Toxicity Study in Rat and or Mice
  • MTD - 14 Day Repeated Dose Toxicity Study in rat with TK
ACF GHS Report