Pharmaceutical Development Services
Smithers 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.
Smithers also offers accredited, third-party auditing and certification to the ISO 13485 quality management system standard for the medical device industry.
Bioanalytical Development Services
Bioanalytical Development Services
Smithers Pharmaceutical Development Services, a bioanalytical CRO, supports the development of large molecule therapeutics from discovery through phase IV.
Single Use Technologies and Processing Equipment
Single Use Technologies and Processing Equipment
Smithers supports the biopharmaceutical manufacturing sector in the compliant and effective use of single use technologies (SUT). Expertise ranges from polymer material selection and suitability to specialist support with control of extractables and leachables.
Pharmaceutical Environmental Risk Assessment
Pharmaceutical Environmental Risk Assessment
The EMA requires that an Environmental Risk Assessment (ERA) accompany every Marketing Authorization Application (MAA) for a new pharmaceutical. Likewise, the US FDA stipulates that a Risk Assessment or Categorical Exclusion claim accompanies every IND, NDA or BLA
Genotoxicity
Genotoxicity
Smithers can help you test new chemical entities for Potential Genotoxic Impurities.
