Introduction to Food Supplementation in Clinical Trials Regulatory Considerations for Swissmedic / [or local responsible EU-CA] and Ethics Proposals Clinical trials involving food supplementation, such as α-D-glucose and 6,6’-d-glucose, require thorough planning and regulatory compliance due to their dual status as food substances and investigational products. While generally recognized as safe under normal dietary circumstances,… Continue reading General Safety & Performance Requirements — Normal and Deuterated-Glucose supplementation related documents
Tag: ISO 9001
Lead EC: General and main site’s documents
Essential BASEC Documents for Ultra-High Field MR Projects Discover the key documents required for submitting an in vivo MR project to BASEC/your local EU-CA/[your local EU-CA/ethics committee], focusing on investigations using non-CE-marked RF coils and pulse sequences, not necessarily, at ultra-high field strengths. In the Table below you find all the documents uploaded to BASEC… Continue reading Lead EC: General and main site’s documents
Demystifying the Investigator’s Brochure: A Comprehensive Guide to Preclinical Testing, Device Interactions, and Regulatory Compliance for Swissmedic and KEK Submissions
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