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• Declarations based on pre-testing of the ingredients we use to standards typically required for medical and diagnostic devices (biological evaluations ISO10993, USP , for class VI devices); and for pharmaceutical packaging and drug-contacting materials (biological evaluation USP, EP chapter and requirements USP and ICHQ3D extractable metals).
• Letter of Authority (LoA) for our Drug Master File (DMF) and Device Master File (MAF).
• Disclosure of ingredients for purpose of regulatory filings (under specific confidentiality agreements).
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