Technology
Oryza has unique capabilities and expertise in modified release technologies, including extended release, sustained release, delayed release, controlled release, pulsatile release, gastrointestinal targeted release, tamper-resistant release, as well as practical application combinations. We also have expertise in solubility and bioavailability enhancements.
Oryza’s scientists have been employing state-of-the-art technologies in the development of special products. These technologies include laser drilling, hot melt extrusion, spray congealing, microfluid, nanoparticle suspension, solid dispersion, and material science in special treatment on solid dosage form products.
Clinical Capabilities
Oryza’s clinical team has on average over 30 years’ experience in drug metabolism, pharmacogenetics, pharmacokinetics, biopharmaceutics, drug-drug, and drug-food interactions, bioavailability, and bioequivalence aspects of generic product development. The team has in-depth knowledge and experience in the design and evaluation of phase I BA/BE studies (for both pharmacokinetics endpoint and clinical endpoint studies) for a wide variety of dosage forms and also a broad experience in clinical trials for new drugs, including Investigational New Drug Applications (INDs) and New Drug Applications (NDAs).The team designed and conducted over 2,000 BA/BE and clinical efficacy trials and participated in more than 200 IND/NDA/ANDA submissions (including Canada, the European Union, Australia, South Africa, China, and the United States) with dozens of first-to-file generic products.
Analytical R&D Laboratories
Oryza Analytical RD Labs specialize in active pharmaceutical ingredient (API) and finished product dosage form testing and evaluation, analytical method development, validation and transfer, and analytical services supporting drug product development and manufacturing, as well as clinical trial materials CTM release and stability testing.
Located in Florida, U.S.A, Oryza’s main Analytical Research and Development Lab is operated by our highly industrial experienced scientists using state-of-art analytical instruments. Working with a network of contract laboratories as our business partners, we extend our Analytical RD services to provide full characterization of drug substances, identification and structural elucidation of unknown impurities, elemental impurity analysis and assessment, and reverse engineering of target products.
