
Experts in Amazon RP, Product Registration, and International Certifications
We help brands achieve full Regulatory/Quality readiness from acting as your Amazon Responsible Person to managing Product Registrations, International Certifications under ISO 9001, ISO 13485, and FDA standards, including Usability Testing.
Amazon Responsible Person (RP)
Stay compliant. Stay listed. Stay selling.
If Amazon flags your listings for missing RP information, your account is at risk in every market you sell in. We act as your official Responsible Person and handle the documentation Amazon and customs authorities require.
Includes:
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FDA registration (USA)
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UKCA marking & UK Responsible Person
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CE marking & EU GPSR compliance
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TGA registration (Australia)
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Label and packaging compliance review
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Technical file preparation
Certifications
The certifications your products need to enter new markets
Entering a new market often means meeting standards you've never had to deal with before. We guide you through the certification process from start to finish — no guesswork, no missed requirements.
Includes
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ISO 13485 / ISO 9001
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MDR / IVDR certification
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FDA standards (QSR 21 CFR Part 820)
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CE / UKCA marking
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Usability engineering / human factors review
Strategic advisory
Strategic guidance for complex regulatory landscapes
Whether you're launching a new product, expanding into a new region, or preparing for an audit, our consulting service gives you a clear roadmap built around your specific market and product category.
Includes
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Regulatory analysis & gap assessment
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Compliance strategy development
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Internal audits
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Team training
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Clinical strategy support
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Market growth planning


