RQM+

CRO Kottmann is a contract research organization focused on delivering specialized services to the medical and pharmaceutical sectors. The company conducts clinical studies involving medical devices, in vitro diagnostics, and pharmaceuticals. Additionally, CRO Kottmann offers tailored services that include the development of electronic case report forms, statistical evaluations, and clinical monitoring for various studies. Committed to customer service and scientific integrity, the organization emphasizes quality throughout its research processes.

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 based in San Diego that focuses on regulatory affairs for the medical device and in vitro diagnostic (IVD) industries. The firm offers comprehensive services, including strategic advisory guidance and support for U.S. FDA regulatory submissions, such as De Novo applications, Premarket Approval (PMA), and Breakthrough Device Designation. AcKnowledge RS leverages a vast network of experienced professionals, including current and former FDA reviewers, scientists, engineers, and regulatory quality experts, to assist clients in achieving compliance with regulatory requirements. Through its expertise, the firm aims to streamline the regulatory process for novel and complex medical devices, helping clients navigate the intricacies of the approval landscape.

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.