Sanray offers high quality analytical testing services to the pharmaceutical industry, regulatory guidance and perform a comprehensive range of quality control testing services to support drug research, registration, development and production.
Sanray pharmaceutical laboratory services provide a wide range of tests, based on your particular requirements, that use cutting edge technology to obtain the data you require to make important business decisions about your products. We also provide regulatory guidance and supply chain assurance that aims to bring quality and safety to support your unique pharmaceutical outsourcing requirements.
We work with you at every stage of product development and production to offer you consistently high quality and customized services that enable you to achieve a competitive edge. We add value to your business by providing high quality technical services and ensuring quality assurance and regulatory compliance.
Sanray helps you achieve a “well-characterized” protein drug substance or drug product by utilizing its expertise in protein analysis including protein structure analysis, physiochemical property determination, potency assays and product-related and process-related impurity testing. With our strengths in identity confirmation, comparability, stability testing and batch release testing we support your product development and production. We also support our customers developing highly complex products by providing characterisation and testing expertise for oligonucleotides, cell and gene therapies, viral species and vaccines. You can ensure a safe and efficacious pharmaceutical product with our expertise in developing and validating assays for bioanalytical pharmacokinetic (PK), toxicokinetic (TK), immunogenicity, and biomarker studies from early discovery through to late-stage clinical studies.
Avail our regulatory-driven, phase-appropriate laboratory services in support of CMC programs through the pre-formulation, formulation and release of your products. Our capabilities include centres of excellence for method development and validation, analysis, stability studies, extractables and leachable, solid state characterisation, elemental impurity analysis, quality control testing and batch release testing. Our industry recognised qualified teams possess expertise in complex medicines and drug delivery systems such as inhalation drug product development for pulmonary and nasal products or biologic therapeutics.
Our bioanalysis experts design and manage strategic work programs during preclinical and clinical development. Our expertise and industry insight aim to supply the answers you need as quickly and efficiently as possible. We also provide immunochemistry services and biomarker expertise for bioanalytical studies, excellence in service delivery and support for your preclinical and clinical development of protein-based therapeutics and other biologic medicines.
Regulatory and Toxicology ConsultingWe offer a fast-track and cost-effective approach to enable you to gain quicker market access for your products and assurance for regulations compliance from discovery to commercialisation of your products.
Pharmaceutical Manufacturing Support
We help your manufacturing to meet its efficiency, safety and compliance goals with our expert cleanroom services, equipment calibration and on-site inspection, while our learning modules equip your workforce with the latest quality and compliance knowledge. Our specialists are trained to perform assessments and prepare reports that are compliant with the EMA guidelines in addition to establishing health-based exposure. Problem solving analysis, supply chain surveillance for counterfeit medicines, counterfeit medicine analysis, expert witness and intellectual property support underpinned by unrivalled materials science experience, supports both manufacturing and post-production.
Bringing quality and safety to life, Sanray delivers innovative pharmaceutical services consistently with precision, pace and passion, enabling you, our customer, to power ahead safely. By meeting your pharmaceutical outsourcing requirements precisely, our team offers a level of assurance, testing, inspection and certification support that adds significant value to your business.