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MERCATI: EMA (EU), FDA (USA), Russian Health Authorities

REGIONE: Europe

COMPLIANCE: FDA (cGMP), ISO, Roszdravnadzor (Russia GMP), EMA (GMP UE)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: COSMETICI, FDF / DRUG PRODUCTS

USO: Umano, Veterinario

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

AREE TERAPEUTICHE DI COMPETENZA (ATC): (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

REGIONE: Europe

MERCATI: FDA (USA), Health Canada (Canada), TGA (Australia)

COMPLIANCE: FDA (cGMP), ISO, Consiglio di ricerca halal, TGA (Australia GMP), EMA (GMP UE), Health Canada (Canada GMP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: NUTRACEUTICI, FDF / DRUG PRODUCTS

USO: Umano

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

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

MERCATI: EMA (EU), FDA (USA)

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

REGIONE: Europe

COMPLIANCE: FDA (cGMP), ISO, IFS, EMA (GMP UE)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: COSMETICI, NUTRACEUTICI, FDF / DRUG PRODUCTS

USO: Umano, Veterinario

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

OEB (Occupational Exposure Banding): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

MERCATI: EMA (EU), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia)

REGIONE: Europe

COMPLIANCE: ISO, Roszdravnadzor (Russia GMP), SFDA (Saudi Food & Drug Authority), EMA (GMP UE)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: COSMETICI, FDF / DRUG PRODUCTS

USO: Umano, Veterinario

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

REGIONE: Europe

SOSTANZE CONTROLLATE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MERCATI: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK)

REGIONE: Europe

COMPLIANCE: FDA (cGMP), ISO, EMA (GMP UE)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano, Veterinario

SERVIZI: Development services, Manufacturing services, Analytical / QC services

AREE TERAPEUTICHE DI COMPETENZA (ATC): (D) Dermatologicals, (H) Systemic hormonal preparations excl. sex hormones and insulins, (N) Nervous system

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

MERCATI: EMA (EU), FDA (USA)

REGIONE: Europe

COMPLIANCE: FDA (cGMP), ISO, EMA (GMP UE), Organizzazione Mondiale della Sanità (GMP / HACCP)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

CATEGORIA / PRODOTTO: NUTRACEUTICI, SERVICES, PARTICLE ENGINEERING

USO: Umano, Veterinario

BSL (Livello di sicurezza biologica): 1, 2

SERVIZI: Development services, Manufacturing services

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

SOSTANZE CONTROLLATE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MERCATI: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities, TGA (Australia)

REGIONE: Europe

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano

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

AREE TERAPEUTICHE DI COMPETENZA (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (P) Antiparasitic products, insecticides and repellents, (A) Digestive tract and metabolism

COMPLIANCE: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (GMP UE), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Repubblica di Corea GMP)

OEB (Occupational Exposure Banding): 4 / HPAPI (PDE = 10 - 100 µg/giorno), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

CATEGORIA / PRODOTTO: SERVICES, FDF / DRUG PRODUCTS

BSL (Livello di sicurezza biologica): 3, 1, 2

MERCATI: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)

REGIONE: Europe

COMPLIANCE: FDA (cGMP), ISO, SFDA (Saudi Food & Drug Authority), Servizio pubblico francese (CIR), EMA (GMP UE)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano, Veterinario

SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

CATEGORIA / PRODOTTO: BIOLOGIA, SERVICES, FDF / DRUG PRODUCTS

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

AREE TERAPEUTICHE DI COMPETENZA (ATC): (V04) Diagnostic agents, (C) Cardiovascular system, (D) Dermatologicals, (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, (A) Digestive tract and metabolism

MERCATI: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities

REGIONE: Europe

DIMENSIONE DEL LOTTO: Grande

USO: Umano

BSL (Livello di sicurezza biologica): 1

SERVIZI: Manufacturing services, Analytical / QC services, Regulatory services, Packaging

SOSTANZE CONTROLLATE: Lowest potential for abuse

COMPLIANCE: ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), NMPA (Cina GMP), EMA (GMP UE), MFDS/KFDA (Repubblica di Corea GMP)

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS

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

BSL (Livello di sicurezza biologica): 3, 1, 2

MERCATI: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), SFDA (Saudi Arabia), MFDS (South Korea), EDE (UAE)

COMPLIANCE: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), Servizio pubblico francese (CIR), EMA (GMP UE)

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano, Veterinario

SERVIZI: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services

REGIONE: North America

CATEGORIA / PRODOTTO: BIOLOGIA, SERVICES, FDF / DRUG PRODUCTS

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

SOSTANZE CONTROLLATE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

MERCATI: EMA (EU), PMDA (Japan), NMPA (China), MHRA (UK), MFDS (South Korea)

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

REGIONE: Europe

DIMENSIONE DEL LOTTO: Grande, Piccolo, Medio

USO: Umano, Veterinario

OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1.000 µg/giorno), 1 / low-hazard (PDE > 10,000 µg/day)

COMPLIANCE: EMA (GMP UE)

CATEGORIA / PRODOTTO: FDF / DRUG PRODUCTS