RQM+

CRO Kottmann is a contract research organization focused on delivering specialized research services to the medical and pharmaceuticals sectors. The company conducts clinical studies involving medical devices, in vitro diagnostics, and pharmaceuticals. In addition to managing these studies, CRO Kottmann offers a range of individual services, including the creation of electronic case report forms, statistical evaluations, and clinical monitoring. The organization emphasizes customer service and quality, ensuring that its scientific research meets the rigorous standards required in the industry.

Libra Medical offers comprehensive contract research organization services tailored for early-stage clinical trials within the biotech and pharmaceutical sectors. They specialize in supporting emerging medical device companies globally, providing expertise in regulatory affairs, clinical operations, and quality assurance.

Jordi Labs specializes in contract analytical laboratory testing services, focusing on the polymer, medical device, and pharmaceutical industries. The company emphasizes chemical identification and has successfully deformulated numerous materials, providing detailed analyses of chemical components and their concentrations. Their range of services includes product failure analysis, HPLC method development, quantitation of polymer fillers and additives, and the identification of unknown substances. Jordi Labs employs various techniques such as liquid and gas chromatography, mass spectroscopy, thermal analysis, microscopy, and elemental and physical testing. This comprehensive approach enables clients to efficiently obtain the necessary analytical services for regulatory compliance, investigative purposes, and quality control.

AcKnowledge Regulatory Strategies is a consulting firm located in San Diego that focuses on regulatory affairs for the medical device and in vitro diagnostic (IVD) industries. The firm specializes in offering strategic advisory services and regulatory submission support for a range of novel and complex devices. This includes assistance with De Novo classifications, Premarket Approval applications, and Breakthrough Device Designation. AcKnowledge Regulatory Strategies leverages an extensive network of current and former FDA reviewers, scientists, engineers, and regulatory quality experts to provide comprehensive guidance. Their services are designed to ensure marketing and labeling compliance while helping clients navigate the intricacies of regulatory processes.

Maetrics is a global life sciences consulting firm focused on regulatory and quality compliance for pharmaceutical, medical device, diagnostics, biotech, and related industries. Founded in 1984 and based in Indianapolis, the company provides regulatory strategies, quality management system improvements, validation and commissioning of facilities, CAPA and corrective actions, supplier quality and supply chain compliance, training, laboratory services, and software tools for performance monitoring in FDA‑regulated environments. Its client base includes Fortune 500 life science companies and organizations worldwide, with engagements across manufacturing, engineering, and quality assurance. Maetrics maintains an international footprint with offices in the United States and Europe, delivering specialized, industry‑focused solutions to help clients stay compliant and competitive.