Wyszukaj i znajdź CMO/CDMO, którego potrzebujesz

RYNKI: EMA (EU), ANVISA (Brazil), ISP (Chile), DIGEMID (Peru), Russian Health Authorities, MHRA (UK), INVIMA (Colombia), SFDA (Saudi Arabia), TGA (Australia)

REGION: APAC, MENA, LATAM, Europa, Ameryka Północna

ZGODNOŚĆ: DIGEMID, ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, SFDA (Saudi Food & Drug Authority), INVIMA, ISP (Chile BPM), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)

ROZMIAR PARTII: Large, Medium

UŻYWAĆ: Human, Veterinary

BSL (poziom bezpieczeństwa biologicznego): 1

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

TERAPEUTYCZNE OBSZARY WIEDZY (ATC): (J) Antiinfectives for systemic use

SUBSTANCJE KONTROLOWANE: Lowest potential for abuse

OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE

RYNKI: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), ANMAT (Argentina), MFDS (South Korea), TGA (Australia)

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

REGION: Europa

ZGODNOŚĆ: FDA (cGMP), ISO, ANVISA (Brazil B-GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

ROZMIAR PARTII: Large, Small, Medium

UŻYWAĆ: Human, Veterinary

TERAPEUTYCZNE OBSZARY WIEDZY (ATC): (C) Cardiovascular system, (M) Musculoskeletal system, (N) Nervous system, (A) Digestive tract and metabolism

SUBSTANCJE KONTROLOWANE: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE

OEB (pasmo narażenia zawodowego): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

RYNKI: EMA (EU)

REGION: Europa

UŻYWAĆ: Human

BSL (poziom bezpieczeństwa biologicznego): 1, 2

USŁUGI: Manufacturing services, Packaging

ROZMIAR PARTII: Small, Medium

ZGODNOŚĆ: EMA (EU GMP)

KATEGORIA / PRODUKT: BIOLOGIA, FDF / PRODUKTY LEKOWE

BSL (poziom bezpieczeństwa biologicznego): 3, 1, 2

RYNKI: EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MHRA (UK), INVIMA (Colombia), MFDS (South Korea), TGA (Australia)

REGION: Europa

ROZMIAR PARTII: Large, Medium

UŻYWAĆ: Human, Veterinary

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

TERAPEUTYCZNE OBSZARY WIEDZY (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism

SUBSTANCJE KONTROLOWANE: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

ZGODNOŚĆ: PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ECOVADIS, INVIMA, ISP (Chile BPM), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE

ZGODNOŚĆ: ICH, FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP)

RYNKI: EMA (EU), FDA (USA)

REGION: Europa

ROZMIAR PARTII: Large, Small, Medium

UŻYWAĆ: Human, Veterinary

KATEGORIA / PRODUKT: OLIGONUKLEOTYDY

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

OEB (pasmo narażenia zawodowego): 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

RYNKI: EMA (EU), FDA (USA), MHRA (UK)

REGION: Europa

ZGODNOŚĆ: FDA (cGMP), French Service-Public (CIR), EMA (EU GMP), MHRA (UK GMP)

ROZMIAR PARTII: Large, Small, Medium

UŻYWAĆ: Human

BSL (poziom bezpieczeństwa biologicznego): 1, 2

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

KATEGORIA / PRODUKT: BIOLOGIA

RYNKI: EMA (EU), NMPA (China), ANVISA (Brazil), Russian Health Authorities, CDSCO (India)

REGION: APAC

ROZMIAR PARTII: Large, Small, Medium

UŻYWAĆ: Human, Veterinary

BSL (poziom bezpieczeństwa biologicznego): 1, 2

KATEGORIA / PRODUKT: CHEMICZNO-SYNTETYCZNY

USŁUGI: Development services, Manufacturing services

TERAPEUTYCZNE OBSZARY WIEDZY (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (R) Respiratory system

SUBSTANCJE KONTROLOWANE: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

ZGODNOŚĆ: World Health Organization (GMP / HACCP)

TERAPEUTYCZNE OBSZARY WIEDZY (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 (pasmo narażenia zawodowego): 5 / HPAPI (PDE < 10 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

RYNKI: NMPA (China), FDA (USA)

REGION: APAC

ZGODNOŚĆ: FDA (cGMP), ISO, NMPA (China GMP)

ROZMIAR PARTII: Large, Small, Medium

UŻYWAĆ: Human, Veterinary

KATEGORIA / PRODUKT: CHEMICZNO-SYNTETYCZNY

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

TERAPEUTYCZNE OBSZARY WIEDZY (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, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

SUBSTANCJE KONTROLOWANE: 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

RYNKI: EMA (EU), PMDA (Japan), NMPA (China), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), MFDS (South Korea), TGA (Australia)

REGION: Europa

ZGODNOŚĆ: FDA (cGMP), PMDA/MHLW (Japan GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

ROZMIAR PARTII: Large, Small, Medium

UŻYWAĆ: Human, Veterinary

KATEGORIA / PRODUKT: CHEMICZNO-SYNTETYCZNY

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

OEB (pasmo narażenia zawodowego): 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

TERAPEUTYCZNE OBSZARY WIEDZY (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, (B) Blood and blood forming organs, (A) Digestive tract and metabolism, (G) Genito urinary system and sex hormones

SUBSTANCJE KONTROLOWANE: 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

RYNKI: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), MHRA (UK), MFDS (South Korea), TGA (Australia)

ZGODNOŚĆ: FDA (cGMP), ISO, ECOVADIS

ROZMIAR PARTII: Large, Small, Medium

UŻYWAĆ: Human, Veterinary

KATEGORIA / PRODUKT: CHEMICZNO-SYNTETYCZNY

USŁUGI: Development services, Manufacturing services

OEB (pasmo narażenia zawodowego): 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

REGION: Ameryka Północna

RYNKI: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MSPAS (Guatemala), COFEPRIS (Mexico), DIGEMID (Peru), MHRA (UK), ANMAT (Argentina), INVIMA (Colombia)

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

REGION: Europa

ZGODNOŚĆ: DIGEMID, FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), MSPAS, COFEPRIS, INVIMA, ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), Health Canada (Canada GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)

ROZMIAR PARTII: Large, Small, Medium

UŻYWAĆ: Human, Veterinary

BSL (poziom bezpieczeństwa biologicznego): 1, 2

OEB (pasmo narażenia zawodowego): 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

KATEGORIA / PRODUKT: BIOLOGIA, FDF / PRODUKTY LEKOWE

RYNKI: EMA (EU), MHRA (UK), TGA (Australia)

REGION: Europa

UŻYWAĆ: Human, Veterinary

BSL (poziom bezpieczeństwa biologicznego): 1

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

OEB (pasmo narażenia zawodowego): 4 / HPAPI (PDE = 10 - 100 µg/day), 2 (PDE = 1,000 - 10,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 10,000 µg/day)

ROZMIAR PARTII: Small, Medium

ZGODNOŚĆ: EMA (EU GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP)

KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE