FUZKK SEGMENTS

Производственные и QC-сегменты

Одна компания может относиться к нескольким сегментам.

API / CDMO / производство

Global API & Biosimilars QC Suite World API Extension QC Suite Ферментация и антибиотические интермедиаты Lumex QC Suite

Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Water Content KF Quality Checker Elemental Impurities ICP Quality Checker LC-MS Confirmation Quality Checker Method Validation Data Packager Process Validation Checker Change Control Impact Checker

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Consumer health / OTC

Китай: пакет утилит по национальному списку основных лекарств Global API & Biosimilars QC Suite

Assay & Impurity HPLC Quality Checker Dissolution Apparatus 1 & 2 Quality Checker Content Uniformity Quality Checker Microbial Enumeration (TAMC/TYMC) Quality Checker Specified Microorganisms Quality Checker Stability Condition Monitoring Quality Checker Packaging Integrity Checker Supplier Evaluation Checker

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Drug delivery и Medical Devices

Medical Devices / стандарты и lifecycle QC Medical Device Risk Management Medical Device Software Electrical Safety & EMC UDI & Labeling

Design Control Compliance Checker Risk Management Report Completeness Checker Risk Control Traceability Checker Requirement Traceability Checker Software Safety Class Checker Data Integrity Security Checker Cybersecurity Risk Assessment Checker Electrical Safety Test Summary Checker

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RNA и генетические лекарства

Китай: пакет утилит по национальному списку основных лекарств Lumex QC Suite LabEx QC Suite Medical Device QMS

Assay & Impurities Result Reviewer Release Readiness Checker Genotoxic Impurity Screener M7 Content Uniformity Acceptance Value Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Water Content KF Quality Checker System Suitability Parameters Checker

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Базовый производственный контур

Китай: пакет утилит по национальному списку основных лекарств Lumex QC Suite LabEx QC Suite Medical Device QMS

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Биопрепараты

Global API & Biosimilars QC Suite LabEx QC Suite

Biologic Aggregate Size Quality Checker Charge Variant CE Quality Checker CE Glycosylation Profiler Protein Concentration UV Quality Checker ELISA Bioassay Quality Checker SPR Binding Affinity Quality Checker Residual Host Cell DNA Quality Checker Residual Host Protein Checker

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Вакцины и препараты плазмы

Huvac — QC утилиты для вакцин человека Плазменные препараты LabEx QC Suite

Vaccine Potency Assessor Adjuvant Aluminum Assay Checker Adjuvant Adsorption Efficiency Quality Checker Inactivated Vaccine Safety Test Quality Checker Live Attenuated Vaccine Genetic Stability Quality Checker Plasma Pool Traceability Checker Plasma Viral Clearance Evidence Checker Cold Chain Shipping Temperature And MKT Quality Checker

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Ветеринарная фарма

Vet — ветеринарные QC утилиты Global API & Biosimilars QC Suite

Herd Flock Vaccine Batch Review Utility Autogenous Vaccine Batch Traceability Utility Antibiotic Potency Assay Checker Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Microbial Enumeration (TAMC/TYMC) Quality Checker

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Готовые формы и small molecules

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Китай: пакет утилит по национальному списку основных лекарств Global API & Biosimilars QC Suite Lumex QC Suite LabEx QC Suite

Assay & Impurities Result Reviewer Assay & Impurity HPLC Quality Checker Residual Solvents GC Quality Checker Water Content KF Quality Checker Elemental Impurities ICP Quality Checker Content Uniformity Quality Checker Dissolution Apparatus 1 & 2 Quality Checker Stability Condition Monitoring Quality Checker

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Диверсифицированная фарма

Китай: пакет утилит по национальному списку основных лекарств Lumex QC Suite LabEx QC Suite Medical Device QMS

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Клеточная и генная терапия

Клеточная и генная терапия / вирусные векторы

Vector Genome Titer q PCR Analyzer Replication Competent Virus RCV Quality Checker Residual Host Cell DNA Quality Checker Residual Host Protein Checker Sterility Test Membrane Filtration Quality Checker Bacterial Endotoxins LAL Quality Checker

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Молекулярная диагностика

Medical Devices / стандарты и lifecycle QC Medical Device Software Medical Device Risk Management

Companion Diagnostic Report Checker Requirement Traceability Checker Software Safety Class Checker Integration Test Coverage Checker Data Integrity Security Checker Cybersecurity Risk Assessment Checker Electrical Safety Test Summary Checker EMCTest Coverage Checker

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Онкология / ADC / high-potency

ADC / конъюгированные биопрепараты Global API & Biosimilars QC Suite

ADC Aggregation Monitor ADC Drug Antibody Ratio Analyzer ADC Free Payload Quantifier ADC Linker Stability Profiler ADCRelease Readiness Checker Assay & Impurity HPLC Quality Checker LC-MS Confirmation Quality Checker Sterility Test Membrane Filtration Quality Checker

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Пептиды и метаболические препараты

Пептиды, GLP‑1 и препараты ожирения

CE Peptide Map Validator CE Peptide Map Fingerprint LC-MS Confirmation Quality Checker Insulin Analog Impurity Checker InsulinHumanHPLCChecker Human Insulin Quality Checker GLP1 Injectable Release Checker Bacterial Endotoxins LAL Quality Checker

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Радиофармацевтика

RPH: объединённый радиофармацевтический QC-пакет Радиолигандная терапия и тераностика

Radionuclidic Purity Checker Bacterial Endotoxins LAL Quality Checker Sterility Test Membrane Filtration Quality Checker Particle Count Injection USP <788> Quality Checker Cold Chain Shipping Temperature And MKT Quality Checker

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Стерильные и инъекционные формы

LabEx QC Suite Sterile Medical Devices Китай: пакет утилит по национальному списку основных лекарств

Sterility Test Membrane Filtration Quality Checker Bacterial Endotoxins LAL Quality Checker Particle Count Injection USP <788> Quality Checker Filter Integrity Test Quality Checker Package Integrity & Leak Test Quality Checker Water For Injections Quality Checker Osmolality Quality Checker Fill Volume & Container Closure Checker

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