Company Category: Regulatory Affairs

DP Distribution & Consulting, LLC

DP Distribution & Consulting, LLC offers a comprehensive set of services to assist clients in their pursuit of compliance and profitability. We work primarily with medical device companies to support their quality and regulatory needs. See our website (www.dpdconline.com) for a full list of our services. | DP Distribution & Consulting, LLC offers a comprehensive set of services to assist clients in their pursuit of compliance and profitability. We work primarily with medical device companies to support their quality and regulatory needs. See our website (www.dpdconline.com) for a full list of our services.

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DHL Global Forwarding

DHL Health Logistics is the dedicated global brand of DHL Group focused on serving the Life Sciences and Healthcare (LSH) sector. The division delivers comprehensive, end‑to‑end logistics solutions across pharmaceuticals, biopharma, medical devices, clinical trials, and consumer health. With over 30 years of experience in healthcare supply chains, DHL Health Logistics integrates a worldwide network spanning 220+ countries, enabling fast, compliant, and reliable delivery of critical healthcare products in optimal condition.

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CS Lifesciences

CS Lifesciences partners with startups, innovators, spin-outs, SMEs, and multinational teams across Ireland, the UK, the EU, and the US, delivering end-to-end Quality, Clinical, and Regulatory support for Medical Devices, IVDs, and Clinical Diagnostics. We help companies move from early development to global commercialization with a practical, compliant roadmap – from US-focused regulatory strategy through to international execution.Our specialists support QMS implementation and remediation, risk management, and day-to-day quality assurance to keep products inspection-ready and patient-safe. On the clinical side, we provide trial design and management, data analysis, and report writing, including robust Clinical Evaluation Reports (CERs) that demonstrate clinical safety and performance.We guide clients through FDA pathways, support regulatory submissions, secure CE marking, and manage post-market surveillance (PMS) to maintain ongoing compliance. We also act as EU/UK Authorised Representative, US Agent, and FDA Initial Importer, making CS Lifesciences a true one-stop consultancy.

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Cormica

Cormica provides comprehensive analytical, microbiological, physical, and biocompatibility testing and consultancy services to support pharmaceutical, medical device, and combination product development from concept to market release. Our mission is to improve patients’ lives by helping manufacturers launch and release safe, compliant products efficiently across the world. With laboratories in the US, UK and EU, Cormica offers end-to-end testing solutions under GMP, GLP, and ISO 17025 accreditation. Our expert teams specialise in analytical chemistry (including extractables and leachables, impurities, method development, and stability studies), microbiology and sterility assurance (bioburden, endotoxin, sterility, and environmental monitoring), and physical and packaging testing (device verification, functional performance, and integrity testing). We also provide biocompatibility testing and regulatory consultancy in accordance with ISO 10993, FDA, and EU and UK MDR requirements.

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ComplianceQuest

Over the last decade, ComplianceQuest has revolutionized organizational dynamics by enhancing culture, collaboration, competency, efficiency, performance, and innovation. Leveraging AI-driven digital transformations in product lifecycle, quality, safety, supplier relationship management and compliance, our 100% Salesforce-powered cloud solutions have been pivotal. Standing as the premier platform, ComplianceQuest uniquely automates compliance operations with an integrated PLM, QMS, SRM and EHS framework. Our intelligent, data-driven approach mitigates risks, safeguarding employees, suppliers, and brand reputation while fostering innovation, compliance, profitability, and customer loyalty. Pre-validated and user-friendly, ComplianceQuest ensures seamless implementation, utilization, and maintenance, facilitating streamlined communication and collaboration throughout the product value chain. | Transform into a fully connected business with a next generation AI powered Product Lifecycle, Quality, Safety, and Supplier Management platform built on Salesforce.Our connected suite of solutions helps businesses of all sizes increase quality, safety, and efficiency as they bring their products from concept to customer success. Our intelligentdata driven platform comes with best in class integrated processes to mitigate risks, protect employees and customers, and strengthen brand reputation.ComplianceQuest is pre validated and easy to implement, easy to use, and easy to maintain. It enables streamlined communication, collaboration, and continuous improvementacross the entire value chain.

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Cambridge Polymer Group

Cambridge Polymer Group Inc. is a contract research laboratory specializing in materials and products. The company’s services range from routing analytical testing to new product research and development. Cambridge provides a high-quality rapid turnaround resource with its multidisciplined, experienced team in all sizes of projects. | Cambridge Polymer Group Inc. is a contract research laboratory specializing in materials and products. The company’s services range from routine analytical testing to new product research and development. Cambridge provides a high-quality rapid turnaround resource with its multi-disciplined, experienced team in all sizes of projects. | Your Material Problems. Our Scientific Experts. One Collaborative Solution. Cambridge Polymer Group provides material science consulting and testing, across your product lifecycle.You have in-depth knowledge of your product and market. CPG is a leader in material science, backed by decades of cross-industry experience. By collaborating, we help you select the right material and develop the most effective design, testing strategies, and manufacturing processes tailored to meet your specific objectives. Together, our combined expertise will accelerate innovation and help you achieve your goals. | Cambridge Polymer Group, Inc. (“CPG”) is a contract research laboratory with over 25 years providing consulting, material/product development, and analytical testing services for clients worldwide with a focus on polymeric materials. We solve the world’s toughest material problems, making safer, more reliable, and more cost-effective health care products and consumer items. Projects range from orthopedic and ophthalmic materials to vibration dampers and EV materials in the automotive industry.

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Bureau Veritas

With a rich history of bringing trust, transparency, and quality assurance to clients and as a Hydrogen Council member, Bureau Veritas is a strategic partner to hydrogen energy players worldwide offering services related to product quality & feedstock testing, emissions, hydrogen risk & safety, supply chain quality, and technical advisory. | Bureau Veritas: Your Trusted Partner in Renewable Energy Excellence For over a century, Bureau Veritas has stood as a global leader in independent testing, inspection, certification, and advisory services. Our legacy of excellence is built on the foundation of thousands of successful projects worldwide, establishing us as a trusted name in the power sector. Powering the Future of Renewable Energy The Bureau Veritas Power group specializes in delivering comprehensive construction management and technical advisory services across the utility-scale renewable energy landscape. Our expertise spans: Wind Energy – Complete project lifecycle support from feasibility studies, construction, commissioning, and operations and maintenance Solar Power – End-to-end services covering feasibility, design, construction, commissioning, and ongoing operations Battery Energy Storage Systems (BESS) – Specialized expertise in battery sizing, system design, and construction oversight Transmission Infrastructure – Expert construction oversight ensuring quality and compliance throughout project delivery Your Advocates Through Every Phase Our team of subject matter experts serves as dedicated advocates for your project throughout its entire lifecycle—from initial feasibility and design through construction, commissioning, and ongoing operations. With Bureau Veritas, you gain a partner committed to ensuring quality, safety, and performance at every stage. Building a sustainable energy future, one project at a time. | As a subsidiary of Bureau Veritas (BV), Bradley Construction Management (Bradley) provides exemplary construction management to the utility-scale renewable-energy market, servicing the onshore wind, solar, battery energy storage and transmission sectors. We aim to be a trusted advisor to our clients, empowering them to make informed decisions about their projects. Backed by BV’s 80,000-plus employees, Bradley is a team of 60 seasoned managers and subject matter experts (SMEs), most of whom are equipped with over 10 years of construction experience. Our industry knowledge provides us to the ability tackle any problem throughout the owner’s engineering and technical advisory, preconstruction and on-site representation stages of a project. Bradley is based in Dallas, Texas, but our site teams can be found spread across North America managing our current projects. | Asset Management and Project Management experts supporting the restaurant industry throughout the Americas. Equipment inventory and Tagging, Open Store Remodels, Facility Assessments, Pre&Post Construction Support, Work Quality Verification, Commissioning, Capital Planning, Multi-Site Consulting.

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BSI Group America, Inc.

Our mission is to ensure patient safety while supporting timely market access to medical technology in a sustainable manner. We strive to set the global standard through conducting impartial, responsive, robust and thorough conformity assessments, evaluations and certifications that are recognized and trusted worldwide.BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme.

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Boulder iQ

Boulder iQ is an expert contract consulting firm providing all the services a life science company needs to get its product to market. With years of experience in regulatory, quality, audit support, product design & development, manufacturing, and contract sterilization, our single-source solution speeds the product development and regulatory submissions process. Our experts help companies navigate through the process of getting medical device, diagnostic and combination products to the market quickly.

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Bennu Product Development

Bennu Product Development specializes in developing safety and reliability-critical products, offering tailored solutions to efficiently bring your ideas to life. Formed by a team with startup experience from a medtech venture, Bennu is driven by the core value of empowering clients to achieve their visions. With a dedicated, experienced design and engineering team, Bennu focuses on collaboratively creating the right device for you.

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