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 provides full clinical life cycle contract research organization services and innovative clinical data management solutions.

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, established in 1984, is a global consulting firm specializing in the life sciences industry. Headquartered in Indianapolis, Indiana, with offices worldwide, the company provides comprehensive solutions to pharmaceutical, medical device, and biotech firms, among others. Maetrics' expertise lies in regulatory compliance, quality management, and supply chain risk assessment. They offer services such as warning letter remediation, quality system improvement, validation, and corrective actions. The firm's unique focus on the life sciences sector enables it to deliver superior insights and maintain a strong client base.