Services for Pharmaceuticals
At Bioneeds, we specialize in supporting preclinical services tailored to meet diverse needs of Pharma industry. Our comprehensive offerings include preclinical drug development services such as IND & NDA enabling studies, impurity qualification, 505(B)2, biodistribution and bridging studies essential for regulatory submissions. We excel in safety evaluation, encompassing DMPK, genetic toxicology, mammalian toxicology, and rigorous formulation & bioanalysis, including method development & validation.
Our multidisciplinary scientific team, led by domain experts, has helped our clients achieve successful and timely project submissions over the years. We are committed to supporting Discovery/Medicinal chemistry, Custom Synthesis, Process R&D, and scalable operations from our cutting-edge 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)
- Tissue / Biodistribution Studies
Routes of Administration
- Oral
- Sublingual
- Intravenous
- Ocular
- Intraocular
- Intracorneal
- Dermal
- Intradermal
- Intramuscular
- Subcutaneous
- Infusion
- Intravitreal
- Inhalation
- Intranasal
- Intratracheal