Jordi Labs, an RQM+ company, delivers regulator-credible testing, toxicology, and scientific consulting that de-risk submissions and get safe MedTech products to patients faster. We are widely recognized for chemical and material characterization and extractables and leachables (E&L) testing.
Our solutions include E&L studies, toxicological risk assessments, biological evaluations, polymer deformulation, unknown identification, and contaminant and failure investigations. Our PhD analytical chemists use a proprietary multi-detector approach frequently cited by regulators and industry to generate precise, decision-ready data.
As part of RQM+, the MedTech CRO, we combine world-class laboratory science with end-to-end regulatory, quality, clinical, and reimbursement expertise, so MedTech teams move from development through post-market with fewer surprises and greater confidence.
With over 45 years of experience, Moravek is a leading provider of high-quality carbon-14 and tritium labeled compounds to researchers worldwide and is one of the most trusted contract development and manufacturing organizations (CDMOs) offering radiosynthesis services. Moravek specializes in the custom production of GMP carbon-14 labeled active pharmaceutical ingredients (APIs) that are manufactured compliant with U.S. Food and Drug Administration (FDA) guidance ICH Q7 Section 19 and are suitable for use in early phase clinical trials. Moravek also offers non-GMP custom synthesis services and an extensive catalog of non-GLP radiolabeled, stable-labeled, and non-labeled compounds.
Separation Methods Technologies, Inc. (SMT) is a surface chemistry research and manufacturing corporation founded in 1993. SMT's goal is to provide chromatographers with outstanding HPLC specialty columns and bulk packing materials for various separation chemistries, ranging from analytical to process scale. The primary focus for SMT is on the creation of well-organized functional molecules on substrate surfaces for various functions, including chromatographic applications and materials engineering.
SMT's novel, patented and proprietary, National Science Foundation awarded, Total Coverage technology utilizes advanced Self-Assembled Monolayers (SAM) to achieve bonded phase coverages that approach 100%. SMT's method of bonding allows the density of the functional ligands to be controlled with appropriate spacer molecules, a procedure that ensures highly cross-linked polysiloxane under layer structure. The results are bonded phases that are well protected and that show unprecedented resistance to both acid and base hydrolysis.
Overall, SMT's HPLC columns and bulk resins are known to challenge many competitors in reusability, high and low pH tolerance and batch-to-batch reproducibility. Therefore, saving our clients time and money.