Pharmaceutical Development Services
Smithers helps pharmaceutical and biopharmaceutical companies develop, test, validate, and bring compliant, effective products to market with confidence.
Our pharmaceutical testing and development services support clients throughout the product lifecycle, from early-stage drug development and regulatory submission through manufacturing, packaging, and distribution.
Capabilities include bioanalytical testing and assay development, extractables and leachables testing, pharmaceutical and packaging analysis, single-use system and processing equipment testing, drug delivery device testing, healthcare packaging and distribution testing, environmental risk assessment, and quality management system auditing and certification.
With scientific expertise, regulatory knowledge, and testing laboratories across the U.S. and Europe, Smithers provides reliable data and practical insights to help pharmaceutical companies meet regulatory requirements, manage risk, solve technical challenges, and accelerate products toward market.
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.
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
Temperature-Controlled Vibration with Pressure Testing for Drug Product Stability
Temperature-Controlled Vibration with Pressure Testing for Drug Product Stability
Smithers provides temperature-controlled vibration with pressure testing to replicate the combined stresses of temperature, vibration, and low pressure during air and cold-chain transport - helping pharmaceutical and biotech organisations assess drug product stability and performance under real-world distribution conditions.
Veterinary Risk Assessment
Veterinary Risk Assessment
Evaluation of environmental risk for veterinary medicines