Pharmaceuticals

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

IND / NDA enabling 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

Genetic Toxicology:

  • Ames test

  • Chromosomal Aberration

  • Micronucleus test

  • Mouse Lymphoma

Safety Pharmacology:

  • hERG

  • Telemetry

  • FOB / Irwin test

  • Respiratory assessment

Immunotoxicity:

  • LLNA

  • Immunohistochemistry

  • TDAR

Analytical capabilities:

  • Formulation method development & validation

  • Bio-analytical method development & validation

Routes of Administration

  • Oral

  • Sublingual

  • Inhalation

  • Intravenous

  • Ocular

  • Dermal

  • Intradermal

  • Intramuscular

  • Intratracheal

  • Subcutaneous

  • Intraocular

  • Intracorneal

  • Infusion


Contact Us @

Phone  +91 80 22658400
+91 816 2214400
+91 98444 57677

Mail Us @

Email  bioneeds@bioneeds.in

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