Regulatory Solutions

AI-powered compliance analysis tailored to your product category. Select your industry to learn more about our specialized regulatory intelligence.

Medical Devices

Comprehensive regulatory gap analysis for EU MDR 2017/745, FDA 510(k), PMA, De Novo pathways, and ISO 13485 quality management systems.

Supported Regulations

EU MDR 2017/745EU IVDR 2017/746FDA 510(k)FDA PMAFDA De NovoISO 13485
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Pharmaceuticals

Full regulatory support for FDA NDA, ANDA, IND submissions and European Medicines Agency guidelines for drug development and approval.

Supported Regulations

FDA NDAFDA ANDAFDA INDEMA GuidelinesICH GuidelinesGMP Compliance
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Dietary Supplements

Navigate DSHEA requirements, 21 CFR 111 cGMP compliance, structure/function claims, and new dietary ingredient notifications.

Supported Regulations

DSHEA21 CFR 111NDI NotificationsLabeling RequirementscGMP Compliance
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