MÄRKTE: EMA (EU)
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: ISO, EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP)
BATCH-GRÖSSE: Groß, Mittel
VERWENDUNG: Menschlich
BSL (Biologische Sicherheitsstufe): 1, 2
THERAPEUTISCHE FACHGEBIETE (ATC): (J) Antiinfectives for systemic use, (R) Respiratory system, (G) Genito urinary system and sex hormones
KATEGORIE/PRODUKT: BIOLOGIEN, FDF / DRUG PRODUCTS
CZ Vaccines | Investigational and Medicinal Products Plant
CZ Vaccines
Einrichtung für klinische Studien
MÄRKTE: EMA (EU), ANVISA (Brazil), CDSCO (India)
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: ISO, ANVISA (Brazil B-GMP), EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP)
VERWENDUNG: Menschlich
BSL (Biologische Sicherheitsstufe): 1, 2
THERAPEUTISCHE FACHGEBIETE (ATC): (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
BATCH-GRÖSSE: Klein
KATEGORIE/PRODUKT: BIOLOGIEN, FDF / DRUG PRODUCTS
MÄRKTE: EMA (EU)
DIENSTLEISTUNGEN: Logistics, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: ISO, EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP)
BATCH-GRÖSSE: Groß, Mittel
VERWENDUNG: Menschlich
BSL (Biologische Sicherheitsstufe): 1, 2
THERAPEUTISCHE FACHGEBIETE (ATC): (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones
KATEGORIE/PRODUKT: BIOLOGIEN, FDF / DRUG PRODUCTS
Cellex Cell Professionals
Cellex Cell Professionals
CGT CDMO Zellfertigungsanlage und Sammelzentrum für Ausgangsmaterialien
MÄRKTE: EMA (EU), FDA (USA)
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: FDA (cGMP), EMA (EU-GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich, Veterinär
BSL (Biologische Sicherheitsstufe): 1, 2
KATEGORIE/PRODUKT: BIOLOGIEN, SERVICES, FDF / DRUG PRODUCTS
CARBOGEN AMCIS | Vionnaz
CARBOGEN AMCIS
Entwicklung hochwirksamer APIs und cGMP-Produktion im kleinen Maßstab, einschließlich Chromatographie und Lyophilisierung.
MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP)
VERWENDUNG: Menschlich, Veterinär
KATEGORIE/PRODUKT: CHEMICAL-SYNTHETIC
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services
OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/Tag), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
BATCH-GRÖSSE: Klein
CARBOGEN AMCIS | Veenendaal
CARBOGEN AMCIS
Großserienfertigung von Cholesterin- und Vitamin-D-Analoga.
THERAPEUTISCHE FACHGEBIETE (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V01) Allergens, (V06) Nutrients, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/Tag), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World
DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
REGION: Europe
COMPLIANCE: DIGEMID, BRCGS, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), IFS, Halal-Forschungsrat, ECOVADIS, TGA (Australia GMP), TITCK (Turkish Health Authorities), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), Französischer Dienst - öffentlich (CIR), NMPA (China GMP), ANMAT (Argentinien neue GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP), SQF (Sichere Lebensmittelqualität), NSF
VERWENDUNG: Menschlich, Veterinär
BSL (Biologische Sicherheitsstufe): 1
KATEGORIE/PRODUKT: CHEMICAL-SYNTHETIC, SERVICES
BATCH-GRÖSSE: Klein
CARBOGEN AMCIS | Saint-Beauzire
CARBOGEN AMCIS
Entwicklung kundenspezifischer Formulierungen und sterile GMP-Herstellung von flüssigen und lyophilisierten Arzneimitteln.
OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/Tag), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, High potential for abuse & no medical use, Lower potential for abuse
MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia), Rest of World
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), Französischer Dienst - öffentlich (CIR), ANMAT (Argentinien neue GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP)
BATCH-GRÖSSE: Groß, Klein, Mittel
VERWENDUNG: Menschlich
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (R) Respiratory system, (S) Sensory organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones
KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS
MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)
REGION: Europe
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), Weltgesundheitsorganisation (GMP / HACCP)
VERWENDUNG: Menschlich, Veterinär
KATEGORIE/PRODUKT: CHEMICAL-SYNTHETIC, SERVICES
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
BATCH-GRÖSSE: Klein, Mittel
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
CARBOGEN AMCIS | Manchester, UK
CARBOGEN AMCIS
Entdecken Sie unsere Kapazitäten zur Herstellung kosmetischer Inhaltsstoffe, Feinchemikalien und kundenspezifischer Synthese von Pharmazwischenprodukten.
REGION: Europe
COMPLIANCE: ISO, Halal-Forschungsrat, ECOVADIS
BATCH-GRÖSSE: Groß, Klein, Mittel
KATEGORIE/PRODUKT: CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CARBOGEN AMCIS | Aarau
CARBOGEN AMCIS
Entwicklung und cGMP-Herstellung im mittleren Maßstab einschließlich Chromatographie.
MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), CDSCO (India), TGA (Australia)
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), Weltgesundheitsorganisation (GMP / HACCP)
VERWENDUNG: Menschlich, Veterinär
KATEGORIE/PRODUKT: CHEMICAL-SYNTHETIC, BIOLOGIEN, SERVICES, PARTICLE ENGINEERING
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services
BATCH-GRÖSSE: Klein, Mittel
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)
CARBOGEN AMCIS | Bubendorf
CARBOGEN AMCIS
Entwicklung und cGMP-Herstellung hochwirksamer Wirkstoffe, einschließlich Antikörper-Wirkstoff-Konjugaten (ADC).
MÄRKTE: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), Turkish Health Authorities, CDSCO (India), TGA (Australia)
REGION: Europe
COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), EMA (EU-GMP), Weltgesundheitsorganisation (GMP / HACCP)
VERWENDUNG: Menschlich, Veterinär
KATEGORIE/PRODUKT: CHEMICAL-SYNTHETIC, BIOLOGIEN, SERVICES, PARTICLE ENGINEERING
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services
THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (L) Antineoplastic and immunomodulating agents, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (V09-10) Radiopharmaceuticals, (B) Blood and blood forming organs, (A) Digestive tract and metabolism
OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/Tag), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/Tag), 1 / low-hazard (PDE > 10,000 µg/day)
BATCH-GRÖSSE: Klein, Mittel
AMSbiopharma
AMSbiopharma
Wir bieten analytische Dienstleistungen zur Unterstützung der pharmazeutischen, biopharmazeutischen und chemischen Industrie in jeder Phase der Arzneimittelentw
COMPLIANCE: ICH, ISO, Weltgesundheitsorganisation (GMP / HACCP)
MÄRKTE: EMA (EU)
REGION: Europe
VERWENDUNG: Menschlich, Veterinär
DIENSTLEISTUNGEN: Development services, Analytical / QC services
KATEGORIE/PRODUKT: SERVICES
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