Pharmaceutical Services
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 for qualification.
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

Exploratory Toxicology Studies
- Dose limiting toxicology studies
- Dose escalation toxicology studies
DMPK Studies / Tests
- In vitro assays
- Caco-2 permeability
- Plasma protein binding
- Solubility
- Microsomal stability
- Blood / Plasma ratio
- CYP assays
- Toxicokinetics (TK) / Pharmacokinetics (PK)
- Bioanalysis
Immunotoxicity
- LLNA
- Immunohistochemistry
- Immunohistochemistry
Analytical Capabilities
- Formulation method development & validation
- Bio-analytical method development & validation
Mammalian Toxicology
- Single dose studies
- Repeated dose studies
- Chronic toxicology studies
- Developmental & reproduction toxicology
Safety Pharmacology Studies
- hERG
- Telemetry
- FOB / Irwin test
- Respiratory assessment
Genetic Toxicology Testing
- Ames test
- Chromosomal aberration
- Micro-nucleus test
- Mouse lymphoma
Routes of Administration
- Oral
- Sublingual
- Inhalation
- Ocular
- Dermal
- Intra dermal
- Intramuscular
- Intratracheal
- Subcutaneous
- Intraocular
- Intracorneal
- Infusion