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Over mij
Hello and welcome! I am a Regulatory Affairs Specialist with expertise in MHRA registration, UKCA certification, FDA compliance, ISO 13485, and MDR technical documentation. I assist businesses, startups, manufacturers, and Amazon sellers in obtaining regulatory approvals for medical devices, cosmetics, and food products. I provide UK Responsible Person (UK RP) services, Declarations of Conformity, eCTD submissions, and compliance consulting, delivering accurate, audit-ready documentation to support efficient regulatory approval.
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