Regulatory Compliance
Navigating the U.S. and European markets can be a formidable challenge for international businesses. Many companies from regions like China, Korea, and India possess certifications and inspection reports that do not align with U.S. or European standards are sometimes deemed invalid, or lack sufficient verification. Moreover, numerous businesses often do not even know which types of certifications are necessary or where to acquire them. America's Supply Chains® is here to provide clarity and guidance.
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You’ve probably seen the words “FDA Approved,” here are some facts about products that are, and aren’t, FDA approved.
10 More Facts about What FDA Does and Does Not Approve | #FDAFacts 11-20.
The growing spread of rumors, misinformation and disinformation about science, medicine, and the FDA, is putting patients and consumers at risk. We’re here to provide the facts.
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Pre-Assessment of Conformity
We begin by evaluating your existing certifications and test results. Our pre-assessment service provides crucial insights into their compatibility with U.S. and European standards, highlighting necessary adjustments and guiding you on which certifications are essential and how to obtain them.
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Product Quality and Safety Assurance
We assist in obtaining the necessary certifications from various U.S. federal agencies, including the Food and Drug Administration (FDA) for healthcare products, the Consumer Product Safety Commission (CPSC) for consumer goods, the Environmental Protection Agency (EPA) for environmental impact standards, the Federal Communications Commission (FCC) for electronic devices, and the Department of Agriculture (USDA) for agricultural products. Additionally, we guide achieving EU-MDR, CE certification for medical devices and healthcare products, ensuring compliance with European Union regulations.
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Intellectual Property Verification
Protecting your innovations is critical. We help verify that your patents and intellectual property rights are enforceable in the U.S. and European market.
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Regulatory Compliance Consulting
Our experts are adept at navigating the complex U.S. regulatory landscape across various sectors. We provide detailed guidance on adhering to environmental laws, health and safety standards, and industry-specific regulations.
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Supply Chain Ethics and Transparency
We support your commitment to ethical business practices. With certifications like SA8000 for social accountability, we ensure your operations align with global standards for sustainability and labor rights.
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Financial Stability and Operational Capability Reviews
Establishing trust is crucial in any partnership. We assess your financial health and operational capabilities to ensure you are seen as a reliable supplier.
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Continuous Support and Updates
Regulations evolve, and so should your compliance strategies. We offer ongoing support to keep you updated with the latest requirements and market developments.
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Contact us today to learn more about the certifications you need and to schedule your pre-assessment!
Join a network of successful companies that have effectively navigated the complexities of entering the U.S. and European markets with our guidance. America's Supply Chains is your partner in achieving compliance, enhancing operational capabilities, and forging reliable partnerships.