Sponsor readiness checklist for FDA’s August 2026 digitally derived endpoints workshop. Covers estimands, validation, data standards, and sensitivity analysis.
A practical guide to FDA’s May 2026 CGT CMC flexibilities, PPQ, specifications, stability, platform knowledge and what BLAs still must show.
Пошаговая проверка китайской IVD-системы в реестре Росздравнадзора: статус, модель, REF, производитель, назначение, документы и отзывы.
2026年1月起俄罗斯临时适用EAEU IVD注册过渡议定书。本指南详解2027/2028关键日期、俄罗斯国家注册与EAEU注册路线对比、决策树、证据清单及常见误读，助中国IVD厂商制定合规策略。
Learn why analytical LoD is not clinical sensitivity and how to evaluate 10 versus 100 CFU/mL claims in molecular tuberculosis tests.
Как российской лаборатории проверить iFIND TBR: исследования, предел обнаружения, расхождения в документах, регистрация и условия внедрения.
Evidence-based procurement guide for the iFIND IFQ INH/FQ fluoroquinolone resistance cartridge: brochure claims, evidence gaps, and a 12-point checklist.
Evidence-based procurement guide for the iFIND TBR MTB/RIF cartridge: peer-reviewed data, brochure claims, regulatory gaps, and 12-point checklist.
面向CRO、IVD、细胞与基因治疗及跨境物流团队，详解海关总署令第281号中特殊货物物品范围、审批材料时限、查验与记录要求，附可打印自查清单与新旧流程对比。
A procurement guide for fully automated molecular POCT systems: what evidence to request before shortlisting a cartridge-based PCR analyzer like RocGene iFIND.