Services
At Smither, we understand the complexities of drug development. Our comprehensive bioanalytical services are designed to meet the rigorous demands of drug development across all phases and therapeutic modalities. With a commitment to accuracy, compliance, and tailored solutions, we effectively facilitate your path from discovery to successful product launch. We have a team of trusted experts in bioanalytical drug development services, supporting all phases and modalities with precision and expertise.
Method Development
Custom bioanalytical method development for small molecules, biologics, and cell and gene therapies across all stages of drug development.
Method Validation
Full method validation studies in compliance with FDA, EMA, and ICH guidelines to ensure accuracy, precision, and reproducibility of bioanalytical methods.
Pharmacokinetics and Toxicokinetics Testing
PK/TK sample analysis supporting ADME studies, dose-response characterisation, and safety assessments throughout preclinical and clinical development.
Immunogenicity Testing
Tiered immunogenicity testing strategies including screening, confirmatory, and neutralising antibody assays to assess anti-drug antibody responses.
Biomarker Services
Biomarker discovery, qualification, and routine analysis using validated platforms to support efficacy, safety, and patient stratification endpoints.
Molecular Biology Services
Advanced molecular biology capabilities including PCR, qPCR, next-generation sequencing, and gene expression analysis for bioanalytical programmes.