Pharmaceutical Services
Bioneeds offers a range of preclinical drug development services including IND & NDA enabling studies, Impurity qualification & Bridging studies for regulatory submissions & 505 (B2) strategies.
Our expertise in safety evaluation spans across DMPK, genetic toxicology, mammalian toxicology, formulation & bioanalysis including method development & validation.
Our multidisciplinary scientific team led by domain experts has helped our clients in successful & timely project submissions over the years.
We also support Discovery / Medicinal chemistry, Custom Synthesis, Process R&D and scale up from our state of the art Chemistry facility.
Exploratory Toxicology Studies
- PK
- Dose Limiting Toxicology Studies
- Dose Escalation Toxicology Studies
- Genotoxicity Screening
DMPK Studies
- In Vitro Assays
- Caco-2 Permeability
- Plasma Protein Binding
- Solubility
- Microsomal Stability
- Blood / Plasma Ratio
- CYP Inhibition Assays
- CYP Induction
Genetic Toxicology Testing
- Ames Test
- Chromosomal Aberration (In Vitro / In Vivo)
- Micronucleus Test (In Vitro / In Vivo)
- Mouse Lymphoma
- Comet Assay
Mammalian Toxicology
- Single Dose Studies
- Repeated Dose Studies
- Chronic Toxicology Studies
- Developmental & Reproduction Toxicology (DART)
Safety Pharmacology Studies
- FOB / Irwin Test
- Telemetry
- Respiratory Assessment
- hERG Assay
Analytical / Bioanalytical Capabilities
- Formulation Method Development, Validation & Dose Formulation Analysis
- Bioanalytical Method Development, Validation & Sample Analysis for Toxicokinetics (TK) / Pharmacokinetics (PK)
Routes of Administration
- Oral
- Sublingual
- Intravenous
- Ocular
- Intraocular
- Intracorneal
- Dermal
- Intradermal
- Intramuscular
- Subcutaneous
- Infusion
- Intravitreal
- Inhalation
- Intranasal
- Intratracheal