Regulatory Compliance Consultants Compare 112 Companies

Regulatory Compliance Consultants:: Regulatory compliance is our primary company objective. Our team, including a former FDA reviewer, has led our customers to regulatory compliance in both US and EU markets. With a focus on 510k submissions, we have a streamlined process of creating and approving required documentation from...
Learn more about Regulatory Compliance Consultants:

Regulatory experts can be difficult to find, especially at reasonable rates. Cadence Regulatory offers strategic counsel as well as medical device market application and document review services for the medical device industry. At Cadence Regulatory, Robert Wolfarth uses over 30 years of...

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,...
Learn more about Regulatory, Quality & Clinical Consulting

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.

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.

Boyd Corporations support encompasses design, prototyping, manufacturing, and global supply chain management, ensuring regulatory compliance with FDA and ISO 13485 standards for medical devices. Leveraging agile and robust supply chains, Boyd Corporation accelerates time to market for clients, offering design for excellence (DFx) services that optimize the product lifecycle from conception through mass production, with a focus on reliability, efficiency, and sustainability, enhancing patient safety and care. Our team is geared to jump in where you need us. Boyd can be a consultant, an extension of your own team, or act as a whole department.

KP Pharmaceutical Technology Inc. advances regulatory compliance consulting that specializes in stability testing services, underscored by our commitment to scientific excellence in CGMP drug development from preclinical through commercial manufacturing. Our comprehensive range of services includes analytical method development, stability-indicating analytical methods, and full regulatory documentation support for FDA submissions like INDs, NDAs, and ANDAs, ensuring compliance with FDA and ICH guidelines. With our expertise, we provide invaluable support in shelf-life assessment, analytical testing under cGMP/cGLP conditions, and complete tech transfer of validated methods, empowering our clients with dependable, regulatory-compliant solutions.