Pharmaceutical Research Services

• Custom synthesis and preparation of active pharmaceutical ingredient (API) in kilogram quantities suitable for Phase I studies. Our highly experienced process chemists can find new ways to build your drug using cost-effective, commercially available materials.
• Custom synthesis and characterization of high-purity reference standards to support analytical method validation and assays.
• Services for custom isotope-labeled materials for bioanalytical applications to support toxicology studies.

Our team excels in the earliest phases of drug discovery and preclinical development, through full cGMP method development and validation. MRIGlobal’s primary focus in pharmaceutical analysis support involves the development and validation of methods for the assay, identity, and purity of new pharmaceutical agents.

Our medical research team analyzes human and animal biological materials to determine their chemical quantities for use in phase I clinical trials. Our capabilities include:

• Kinetic studies
• Validation & modeling reports
• Customized protocol
• Formulation studies

Our repository services enhance your project by providing expert procurement, receipt, storage, and distribution for a wide range of materials. We have experience handling everything from natural substances to toxic chemicals.

Our biorepository team ensures your project’s success by providing expert procurement, receipt, storage, and distribution for a wide range of biological materials. We have experience handling both human and animal specimens for use in clinical trials and disease diagnostics.

We provide stability study testing per International Council of Harmonization (ICH) guidelines for set temperature and humidity ranges. MRIGlobal tests at requisite intervals with parameters specified by our customer and based on the drug substance or product’s manufacturing conditions.