Regulatory Compliance Consultants Compare 116 Companies

At Fort Wayne Metals, we specialize in developing high-performance wire-based solutions that meet the most demanding applications for businesses across medical and non-medical markets. We offer a wide range of advanced materials, including stainless steel, titanium, Nitinol, refractory metals,...

At Marubeni Citizen-Cincom (MCC), we specialize in providing advanced precision machining solutions for business-to-business clients across industries, leveraging decades of expertise since our founding in 1984. As a collaboration between Marubeni Corporation and Citizen Machinery Co., two of...

HaA Product Development offers a comprehensive suite of regulatory compliance consultation services, ensuring that products not only meet but exceed the stringent standards set by medical industry regulations including FDA QSR 21 CFR 820 and ISO 13485:2016. Leveraging our deep expertise and tailored methodologies, HaA provides robust support to navigate the complexities of regulatory pathways, enhancing the speed and efficiency of bringing medical devices to market while ensuring full compliance and operational excellence.

Health Canada Compliance: Health Canada Compliance for Medical Devices and Health Care Products Marketing Medical Devices in Canada, the manufacturers, private labelers, importers, and distributors of Medical Devices are required to meet all requirements of the Canadian Federal Regulatory Authority, and its agency...
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The Realtime Group offers expert regulatory compliance consulting that integrates seamlessly with multidisciplinary engineering services for the medical device industry. Utilizing multiple methodologies, such as human-centered design, risk management, cybersecurity assessments, and comprehensive verification and validation processes, we ensure that your product meets rigorous regulatory standards and achieves market success. Our dedication to quality management and proof-of-compliance systems supports you through every step of development, offering peace of mind and a competitive edge in rapidly evolving regulatory landscapes, ensuring faster time-to-market, enhanced product safety and efficacy, and market success.

ProPharma Group is a global leader in regulatory compliance consulting, offering unparalleled support throughout the full product lifecycle for medical devices. Leveraging a unique blend of scientific expertise and regulatory insight, our services encompass pre- and post-approval strategies, FDA and EMA compliance. Our seasoned consultants leverage deep scientific knowledge and a strategic approach, optimizing every critical milestone from investigational new drug applications to post-authorization and commercialization, ensuring your product maintains optimal regulatory status and achieves successful outcomes.

Regulatory, Quality & Clinical Consulting: Strategic Regulatory Consulting & Submissions PMA, 510(k), NDA, IND, IDE / HDE Submissions, Amendments, Reporting & Supplements Laser Product Radiation Reports Establishment Registrations Device Listings Experienced U.S. Agent Negotiations with Government Agencies International Dossiers,...
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Polymer Solutions Incorporated (PSI) offers regulatory compliance consulting that delivers exceptional quality assurance and compliance services, grounded in our comprehensive understanding of stringent quality frameworks and regulatory standards. Leveraging a robust Quality Management System and cutting-edge electronic document management technology, we guarantee data reliability, methodological integrity, and regulatory adherence, essential for FDA submissions and international compliance. With a focus on custom method development, meticulous release testing for production lots, and end-to-end support for failure investigations, PSI empowers you with defensible documentation and results, ensuring your products meet the highest standards of safety and quality.

Valoit Inc. is a preeminent provider of FDA and SOX regulatory compliance services, catering to the pharmaceutical, biotechnology, medical device, and diagnostic industries with a blend of audit assessments, validation, and quality assurance services. Our expertise in engineering design, information technology, process controls, and comprehensive understanding of cGXPs sets us apart, ensuring a reliable, end-to-end solution for technology and regulatory compliance challenges. With a focus on computer system and automation validations, including SAP, ERP, MRP, MES, PLCs, DCS, SCADA, LIMS, and EDMS, Valoit equips you with the necessary tools and knowledge to maintain compliance efficiently, leveraging sophisticated methodologies for equipment validation to achieve seamless regulatory alignment and high-quality execution on projects across enterprise and automated systems.

At DeRoyal Industries Inc., we provide regulatory compliance consulting with a steadfast commitment to quality, as evidenced by our comprehensive adherence to ISO 13485:2016 and MDSAP certifications across all our medical products and services. Our team of experts employs a meticulous approach to ensure our practices not only meet but exceed the stringent requirements imposed by regulatory bodies, providing you and your patients with products of unparalleled reliability and safety.