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Integrated Discovery, Development  &

Regulatory Services

Pharmaceuticals

Bioneeds is the One Stop Solution for Safety evaluation – IND, NDA enabling and other safety studies

Our expertise for global IND-enabling safety evaluation spans across mammalian toxicology, genetic toxicology, DMPK, and bio-analysis during the preclinical stage of drug development including method development, validation, impurity profiling, impurity isolation, characterization, certification and evaluation.

In addition Bioneeds’ NDA / ANDA enabling safety evaluations encompasses a comprehensive portfolio of ADMET assays.

Our scientific team led by domain experts has helped clients in successful & timely submissions over the years.

Compound Synthesis: Importantly, Bioneeds can also generate the test material required for preclinical evaluation in its state-of-the-art Chemistry facility.

Exploratory Toxicology Studies:

  • Dose limiting toxicology studies
  • Dose escalation toxicology studies

DMPK:

  • Caco-2 permeability
  • Plasma protein binding
  • Solubility
  • Microsomal/S9 stability
  • Blood / Plasma ratio
  • CYP liabilities
  • Pharmacokinetics / Toxicokinetics
  • Tissue distribution

Mammalian Toxicology:

  • Single dose studies
  • Repeated dose studies
  • Chronic toxicology studies
  • Developmental & Reproduction toxicology

Safety Pharmacology:

  • hERG
  • Telemetry
  • FOB / Irwin test
  • Respiratory assessment

Genetic Toxicology:

  • Ames test
  • Chromosomal Aberration
  • Micro-nucleus test
  • Mouse Lymphoma

Immunotoxicity:

  • LLNA
  • Immunohistochemistry
  • TDAR

Analytical capabilities:

  • Formulation method development & validation
  • Bio-analytical method development & validation

Routes of Administration

  • Oral
  • Sublingual
  • Inhalation
  • Intravenous
  • Ocular
  • Dermal
  • Intra dermal
  • Intramuscular
  • Intratracheal
  • Subcutaneous
  • Intraocular
  • Intracorneal
  • Infusion
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