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)

REGION: Europa

ZGODNOŚĆ: ISO, EMA (EU GMP)

ROZMIAR PARTII: Large, Medium

KATEGORIA / PRODUKT: NUTRACEUTYKI, FDF / PRODUKTY LEKOWE

UŻYWAĆ: Veterinary

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

SUBSTANCJE KONTROLOWANE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

ZGODNOŚĆ: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU GMP), Health Canada (Canada GMP), MFDS/KFDA (Republic of Korea GMP)

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

ROZMIAR PARTII: Large, Medium

UŻYWAĆ: Human

KATEGORIA / PRODUKT: CHEMICZNO-SYNTETYCZNY, USŁUGI, FDF / PRODUKTY LEKOWE, INŻYNIERIA CZĄSTEK

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

TERAPEUTYCZNE OBSZARY WIEDZY (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: Ameryka Północna

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)

SUBSTANCJE KONTROLOWANE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

ZGODNOŚĆ: ICH, FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TGA (Australia GMP), EMA (EU GMP), Health Canada (Canada GMP), MHRA (UK GMP), MFDS/KFDA (Republic of Korea GMP)

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

ROZMIAR PARTII: Large, Small, Medium

UŻYWAĆ: Human

KATEGORIA / PRODUKT: CHEMICZNO-SYNTETYCZNY, USŁUGI, FDF / PRODUKTY LEKOWE, INŻYNIERIA CZĄSTEK

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

TERAPEUTYCZNE OBSZARY WIEDZY (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: Ameryka Północna

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)

SUBSTANCJE KONTROLOWANE: High potential for abuse & medical use, Lowest potential for abuse, Low potential for abuse, Lower potential for abuse

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

REGION: Europa

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

UŻYWAĆ: Human

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

ROZMIAR PARTII: Small, Medium

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

RYNKI: 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)

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, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), INVIMA, ISP (Chile BPM), French Service-Public (CIR), NMPA (China GMP), 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

TERAPEUTYCZNE OBSZARY WIEDZY (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

KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE

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

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), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), MFDS (South Korea), Turkish Health Authorities

REGION: Europa

ZGODNOŚĆ: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

ROZMIAR PARTII: Large, Small, Medium

KATEGORIA / PRODUKT: KOSMETYKI, NUTRACEUTYKI, FDF / PRODUKTY LEKOWE, INŻYNIERIA CZĄSTEK

UŻYWAĆ: Human, Veterinary

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

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), FDA (USA), ANVISA (Brazil), Russian Health Authorities, MFDS (South Korea), Turkish Health Authorities

REGION: Europa

ZGODNOŚĆ: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), EMA (EU GMP), MFDS/KFDA (Republic of Korea GMP)

ROZMIAR PARTII: Large, Small, Medium

UŻYWAĆ: Human, Veterinary

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

TERAPEUTYCZNE OBSZARY WIEDZY (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins

KATEGORIA / PRODUKT: FDF / PRODUKTY LEKOWE

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), FDA (USA), ANVISA (Brazil), Russian Health Authorities

REGION: Europa

ZGODNOŚĆ: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), EMA (EU GMP)

ROZMIAR PARTII: Large, Small, Medium

KATEGORIA / PRODUKT: NUTRACEUTYKI, FDF / PRODUKTY LEKOWE

UŻYWAĆ: Human

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

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)

RYNKI: EMA (EU), FDA (USA), ANVISA (Brazil), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities

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

REGION: Europa

ZGODNOŚĆ: FDA (cGMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), TITCK (Turkish Health Authorities), SFDA (Saudi Food & Drug Authority), EMA (EU 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: FDF / PRODUKTY LEKOWE

RYNKI: EMA (EU), PMDA (Japan), FDA (USA), ANVISA (Brazil), Russian Health Authorities, EDE (UAE)

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

REGION: Europa

ZGODNOŚĆ: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), Roszdravnadzor (Russia GMP), UAE Ministry of Health & Prevention, EMA (EU GMP)

ROZMIAR PARTII: Large, Small, Medium

UŻYWAĆ: Human, Veterinary

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

RYNKI: EMA (EU), FDA (USA)

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

REGION: Europa

ZGODNOŚĆ: FDA (cGMP), ISO, IFS, EMA (EU GMP)

ROZMIAR PARTII: Large, Small, Medium

KATEGORIA / PRODUKT: KOSMETYKI, NUTRACEUTYKI, FDF / PRODUKTY LEKOWE

UŻYWAĆ: Human, Veterinary

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)