Seans 11 udogodnienia
Szwajcaria
CARBOGEN AMCIS | Bubendorf
CARBOGEN AMCIS
Rozwój i produkcja cGMP wysoce silnego API, w tym koniugatów przeciwciał i leków (ADC).
Markets: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
Batch Size: Small, Medium
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (V09-10) Radiopharmaceuticals, (M) Musculoskeletal system, (L) Antineoplastic and immunomodulating agents, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (B) Blood and blood forming organs
Compliance: EMA (EU GMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO
Category / Product: ANALITYCZNE CRO, PARTICLE ENGINEERING, BIOLOGICS, CHEMICAL-SYNTHETIC
Region: Europe
Use: Human, Veterinary
Services: Analytical / QC services, Manufacturing services, Regulatory services, Development services, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Hiszpania
53Biologics Production Plant
53Biologics
53Biologics to hiszpańska CDMO specjalizująca się w dekodowaniu produkcji leków biologicznych, od DNA po białka.
Markets: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), TGA (Australia), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
Batch Size: Small, Medium, Large
Compliance: EMA (EU GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO
Region: Europe
Use: Human, Veterinary
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Quality Assurance services
Category / Product: BIOLOGICS
BSL (Biological Safety Level): 1, 2
Ograniczony widok
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Wczesna faza sterylnego wykończenia wypełnienia
Lokalizacja dostępna po rejestracji
Ograniczony widok
BIOLOGICS manufacturing site
MAI network supplier
Niesterylny obiekt kliniczny (doustne dawki stałe)
Lokalizacja dostępna po rejestracji
Ograniczony widok
FDF / DRUG PRODUCTS manufacturing site
MAI network supplier
Kompleksowe rozwiązania CDMO dla APl i kluczowych półproduktów.
Lokalizacja dostępna po rejestracji
Sugerowane wyniki
Obiekty te spełniają Twoje główne kryteria, ale nie wszystkie opcjonalne filtry.
Hiszpania
HIPRA BIOTECH SERVICES | Amer
HIPRA Biotech Services
Kompleksowe możliwości wewnętrzne, od rozwoju linii komórkowych po produkcję komercyjną.
Markets: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Compliance: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), ISO, INVIMA, Health Canada (Canada GMP), MSPAS, COFEPRIS
Region: Europe
Use: Human, Veterinary
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
BSL (Biological Safety Level): 1, 2
Hiszpania
BDI biotech Production Plant
BDI biotech
Pracujemy jako dział badawczo-rozwojowy specjalizujący się w opracowywaniu szczepów i bioprocesów, zwiększaniu skali i produkcji seryjnej.
Markets: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), TGA (Australia), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
Batch Size: Small, Medium
Region: Europe
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services
Category / Product: BIOLOGICS
BSL (Biological Safety Level): 1
Compliance: ISO
Holandia
Bilthoven Biologicals Drug Substance and Drug Product Facilities
Bilthoven Biologicals BV
Wieloproduktowe obiekty GMP dla substancji i produktów leczniczych.
Batch Size: Small, Medium, Large
Category / Product: FDF / DRUG PRODUCTS, ANALITYCZNE CRO, BIOLOGICS
Compliance: EMA (EU GMP)
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
BSL (Biological Safety Level): 1, 2
Markets: EMA (EU), MHRA (UK)
Hiszpania
CZ Vaccines | Investigational and Medicinal Products Plant
CZ Vaccines
Ośrodek Badań Klinicznych
Batch Size: Small
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (G) Genito urinary system and sex hormones, (A) Digestive tract and metabolism
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Compliance: EMA (EU GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), ISO
Region: Europe
Markets: ANVISA (Brazil), CDSCO (India), EMA (EU)
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
BSL (Biological Safety Level): 1, 2
Szwajcaria
CARBOGEN AMCIS | Aarau
CARBOGEN AMCIS
Rozwój i produkcja cGMP na średnią skalę, w tym chromatografia.
Batch Size: Small, Medium
Compliance: PMDA/MHLW (Japan GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO
Category / Product: ANALITYCZNE CRO, PARTICLE ENGINEERING, BIOLOGICS, CHEMICAL-SYNTHETIC
Region: Europe
Markets: ANVISA (Brazil), PMDA (Japan), FDA (USA), CDSCO (India), EMA (EU), MFDS (South Korea), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)
Use: Human, Veterinary
Services: Analytical / QC services, Manufacturing services, Development services, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
Hiszpania
HIPRA BIOTECH SERVICES | Aiguaviva
HIPRA Biotech Services
Kompleksowe możliwości wewnętrzne, od rozwoju linii komórkowych po produkcję komercyjną.
Markets: DIGEMID (Peru), ANMAT (Argentina), ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), EMA (EU), COFEPRIS (Mexico), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)
Batch Size: Small, Medium, Large
Compliance: ISP (Chile BPM), ANMAT (Argentina nueva GMP), EMA (EU GMP), PMDA/MHLW (Japan GMP), DIGEMID, ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), MHRA (UK GMP), FDA (cGMP), ISO, INVIMA, Health Canada (Canada GMP), MSPAS, COFEPRIS
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
OEB (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day)
Category / Product: BIOLOGICS
BSL (Biological Safety Level): 1, 2
Batch Size: Medium, Large
Therapeutic Areas of Expertise (ATC): (R) Respiratory system, (G) Genito urinary system and sex hormones, (J) Antiinfectives for systemic use
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Compliance: EMA (EU GMP), World Health Organization (GMP / HACCP), ISO
Region: Europe
Use: Human
Services: Analytical / QC services, Logistics, Manufacturing services, Regulatory services, Development services, Packaging, Quality Assurance services
BSL (Biological Safety Level): 1, 2
Markets: EMA (EU)
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