Pharmaceutical Services
Pharmaceutical Services at Bioneeds provide integrated preclinical support for pharmaceutical development programs. Our capabilities include IND & NDA–enabling studies, impurity qualification, 505(b)(2) development, biodistribution, and regulatory bridging studies.
We specialize in safety assessment through DMPK, genetic and mammalian toxicology, along with formulation development and bioanalytical services, including method development and validation. Guided by a highly experienced scientific leadership team, Bioneeds supports discovery through scale-up via Medicinal Chemistry, Custom Synthesis, Process R&D, and advanced chemistry infrastructure.
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