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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, 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), 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: ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), NMPA (China GMP), EMA (EU-GMP), MFDS/KFDA (Republik Korea GMP)

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich

BSL (Biologische Sicherheitsstufe): 1, 2

THERAPEUTISCHE FACHGEBIETE (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins, (L) Antineoplastic and immunomodulating agents, (N) Nervous system

KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS

KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

COMPLIANCE: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), MFDS/KFDA (Republik Korea GMP)

MÄRKTE: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), TGA (Australia)

BATCH-GRÖSSE: Groß, Mittel

VERWENDUNG: Menschlich

KATEGORIE/PRODUKT: CHEMICAL-SYNTHETIC, SERVICES, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING

DIENSTLEISTUNGEN: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (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, (R) Respiratory system, (S) Sensory organs, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

REGION: North America

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)

BSL (Biologische Sicherheitsstufe): 3, 1, 2

KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MÄRKTE: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), MFDS (South Korea)

REGION: Europe

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich

DIENSTLEISTUNGEN: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (J) Antiinfectives for systemic use, (L) Antineoplastic and immunomodulating agents, (N) Nervous system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

KATEGORIE/PRODUKT: SERVICES, FDF / DRUG PRODUCTS

KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

COMPLIANCE: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (EU-GMP), Gesundheit Kanada (Kanada GMP), MHRA (UK GMP), MFDS/KFDA (Republik Korea GMP)

MÄRKTE: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), MFDS (South Korea), TGA (Australia)

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich

KATEGORIE/PRODUKT: CHEMICAL-SYNTHETIC, SERVICES, FDF / DRUG PRODUCTS, PARTICLE ENGINEERING

DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (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, (R) Respiratory system, (S) Sensory organs, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

REGION: North America

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)

MÄRKTE: EMA (EU), MHRA (UK)

DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGION: Europe

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich

BSL (Biologische Sicherheitsstufe): 1, 2

COMPLIANCE: EMA (EU-GMP)

KATEGORIE/PRODUKT: BIOLOGIEN, SERVICES, FDF / DRUG PRODUCTS

KONTROLLIERTE SUBSTANZEN: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MÄRKTE: EMA (EU), PMDA (Japan), Health Canada (Canada), DIGEMID (Peru), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), TGA (Australia)

REGION: Europe

COMPLIANCE: ISO, UAE Ministry of Health & Prevention, EMA (EU-GMP)

VERWENDUNG: Menschlich

DIENSTLEISTUNGEN: Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging

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)

KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (B) Blood and blood forming organs, (A) Digestive tract and metabolism

MÄRKTE: MHRA (UK), ANMAT (Argentina), INVIMA (Colombia), MFDS (South Korea), CDSCO (India), TGA (Australia), EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), Russian Health Authorities

BATCH-GRÖSSE: Klein, Mittel

COMPLIANCE: EMA (EU-GMP), ISO

KATEGORIE/PRODUKT: BIOLOGIEN, SERVICES, FDF / DRUG PRODUCTS, KOSMETIK

REGION: Europe

VERWENDUNG: Menschlich, Veterinär

BSL (Biologische Sicherheitsstufe): 1, 2

DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services

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), MFDS (South Korea), EDE (UAE), TGA (Australia)

DIENSTLEISTUNGEN: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging

REGION: Europe

COMPLIANCE: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), 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)

BATCH-GRÖSSE: Groß, Klein, Mittel

VERWENDUNG: Menschlich

THERAPEUTISCHE FACHGEBIETE (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

KATEGORIE/PRODUKT: FDF / DRUG PRODUCTS

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)

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

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

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