Pharmaceutical Development Services
Smither Pharmaceutical Development Services, a contract research organization (CRO), offers a comprehensive range of pre-clinical and clinical drug development services, including support for development of drug delivery devices, and medical and pharmaceutical packaging testing.
Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP- and GCP-compliant laboratories.
We conduct environmental risk assessments/environmental assessments to support registration in the EU and US for our pharmaceutical clients.
Smither also offers accredited, third-party auditing and certification to the ISO 13485 quality management system standard for the medical device industry.
Bioanalytical
GLP- and GCP-compliant bioanalytical services for large and small molecules, including ligand binding assays, LC-MS/MS quantification, immunogenicity testing, and biomarker analysis across all phases of drug development.
Extractables and Leachables
Comprehensive extractables and leachables (E&L) studies for pharmaceutical packaging, drug delivery devices, and single-use systems — performed to ICH Q3 guidelines, ISO 10993, and USP requirements.
Single Use Technologies and Processing Equipment
Testing and evaluation of single-use bioprocessing equipment including bags, tubing, connectors, and filter systems — covering extractables, biological safety, and functional performance for biopharmaceutical manufacturing.
Pharmaceutical Environmental Risk Assessment
Environmental risk assessments (ERA) for pharmaceutical compounds to support EU and US regulatory submissions, including PBT/vPvB analysis, ecotoxicology testing, and environmental fate studies.
Genotoxicity
Full suite of in vitro and in vivo genotoxicity studies including Ames test, MNT, chromosome aberration, and comet assay — conducted under GLP to support ICH S2(R1) and regulatory agency requirements.
Temperature-Controlled Vibration with Pressure Testing for Drug Product Stability
Specialised stability testing combining controlled temperature, vibration, and pressure cycling to simulate cold-chain distribution stresses on pharmaceutical products, parenteral packaging, and biologics.
Veterinary Risk Assessment
Environmental and safety risk assessments for veterinary medicinal products, including ecotoxicology studies, environmental fate, and regulatory dossier preparation to VICH GL6 and EMA guidelines.
Conferences
Smither hosts leading pharmaceutical and life science conferences covering extractables and leachables, bioanalysis, and drug development topics — connecting experts and driving industry advancement.
Market Reports
Authoritative pharmaceutical market intelligence covering drug delivery devices, packaging, contract services, and emerging therapeutic modalities — supporting strategic planning and investment decisions.