Seans 218 udogodnienia
Hiszpania
HIPRA BIOTECH SERVICES | Amer
HIPRA Biotech Services
Kompleksowe możliwości wewnętrzne, od rozwoju linii komórkowych po produkcję komercyjną.
Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Markets: 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)
Compliance: 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)
BSL (Biological Safety Level): 1, 2
Use: Human, Veterinary
Batch Size: Large, Small, Medium
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS, BIOLOGICS
Region: Europe
Słowenia
JAFRAL
JAFRAL
Zintegrowany zakład biotechnologiczny zapewniający badania i rozwój, produkcję niezgodną z GMP i GMP, testy kontroli jakości oraz usługi napełniania i wykończenia zaawansowanych produktów…
Services: Development services, Logistics, Analytical / QC services, Packaging, Regulatory services, Quality Assurance services, Manufacturing services
Compliance: ICH, FDA (cGMP), ISO, EMA (EU GMP), World Health Organization (GMP / HACCP), SQF (Safe Quality Food)
Markets: EMA (EU), PMDA (Japan), FDA (USA), Health Canada (Canada), ANVISA (Brazil), MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, EDE (UAE), CDSCO (India), TGA (Australia)
BSL (Biological Safety Level): 1, 2
Category / Product: COSMETICS, NUTRACEUTICALS, FDF / DRUG PRODUCTS, SERVICES, BIOLOGICS
Use: Human, Veterinary
Batch Size: Large, Small, Medium
Controlled Substances: Lowest potential for abuse
Therapeutic Areas of Expertise (ATC): (J) Antiinfectives for systemic use, (D) Dermatologicals, (V06) Nutrients, (R) Respiratory system, (A) Digestive tract and metabolism
Region: Europe
Słowacja
HBM Pharma
Hbm Pharma
CMO z certyfikatem GMP UE z siedzibą w Martinie na Słowacji. Firma świadczy usługi produkcyjne i konfekcjonowania sterylnych produktów farmaceutycznych. produkty i stałe doustne postacie dawkowania
Markets: EMA (EU), NMPA (China), Health Canada (Canada), ANVISA (Brazil), COFEPRIS (Mexico), Russian Health Authorities, MHRA (UK), SFDA (Saudi Arabia), Turkish Health Authorities, TGA (Australia)
Compliance: ISO, Roszdravnadzor (Russia GMP), ECOVADIS, TGA (Australia GMP), UAE Ministry of Health & Prevention, NMPA (China GMP), EMA (EU GMP), Health Canada (Canada GMP), ANVISA (Brazil)
Use: Human
Batch Size: Large, Small, Medium
Services: Analytical / QC services, Packaging, Quality Assurance services, Manufacturing services
OEB (Occupational Exposure Banding): 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day)
Controlled Substances: High potential for abuse & medical use
Category / Product: FDF / DRUG PRODUCTS, SERVICES
Region: Europe
Szwajcaria
SENN Chemicals | R&D and Kilo Lab | Dielsdorf, Switzerland
Senn Chemicals
Szwajcarski ośrodek badawczo-rozwojowy dotyczący peptydów i półproduktów peptydowych obejmujący SPPS, LPPS, syntezę hybrydową, zwiększanie skali laboratoryjnej
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Category / Product: COSMETICS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING
Batch Size: Small
Szwajcaria
SENN Chemicals | Small Scale GMP Lab | Dielsdorf, Switzerland
Senn Chemicals
Laboratorium peptydów GMP i syntezy organicznej na małą skalę do projektów klinicznych, niszowych i o wysokiej wartości, wymagających elastycznej produkcji cGMP
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Category / Product: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING
Batch Size: Small
Szwajcaria
SENN Chemicals | GMP Production | Dielsdorf, Switzerland
Senn Chemicals
Szwajcarski zakład produkcyjny cGMP do produkcji LPPS, SPPS i peptydów hybrydowych od pilotażu do wczesnej skali komercyjnej.
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: Europe
Batch Size: Large, Medium
Category / Product: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING
Indie
SENN India | Non-GMP Plant | Hyderabad, India
Senn Chemicals
Zakład produkcyjny na dużą skalę niezgodny z GMP, zajmujący się półproduktami peptydowymi, syntezą organiczną, operacjami LPPS i produkcją na większą skalę.
Services: Logistics, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Region: APAC
Batch Size: Large, Small, Medium
Category / Product: COSMETICS, CHEMICAL-SYNTHETIC, SERVICES, PARTICLE ENGINEERING
Indie
SENN India | R&D Lab | Hyderabad, India
Senn Chemicals
Centrum badawczo-rozwojowe w dziedzinie chemii peptydów i organicznej z SPPS, oczyszczaniem, liofilizacją, analityką i wsparciem w zakresie inżynierii cząstek.
Services: Logistics, Development services, Analytical / QC services, Quality Assurance services, Packaging
Region: APAC
Category / Product: CHEMICAL-SYNTHETIC, PARTICLE ENGINEERING
Batch Size: Small
Hiszpania
Laboratorio REIG JOFRE, SA (BARCELONA PLANT)
LABORATORIO REIG JOFRE SA
Zakłady produkujące produkty do wstrzykiwania (lyo i płyn) oraz płynne.
BSL (Biological Safety Level): 3, 1, 2
Markets: EMA (EU), PMDA (Japan), Health Canada (Canada), ANVISA (Brazil), ISP (Chile), MHRA (UK), INVIMA (Colombia), MFDS (South Korea), TGA (Australia)
Region: Europe
Batch Size: Large, Medium
Use: Human, Veterinary
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Therapeutic Areas of Expertise (ATC): (C) Cardiovascular system, (D) Dermatologicals, (J) Antiinfectives for systemic use, (N) Nervous system, (R) Respiratory system, (A) Digestive tract and metabolism
Controlled Substances: Lowest potential for abuse, Low potential for abuse, Lower potential for abuse
Compliance: 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 (Occupational Exposure Banding): 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 1 / low-hazard (PDE > 5,000 µg/day)
Category / Product: FDF / DRUG PRODUCTS
Hiszpania
VIVEbiotech
VIVEbiotech
Twoje wiodące CDMO z certyfikatem GMP, przeznaczone wyłącznie do produkcji wektorów lentiwirusowych.
Markets: EMA (EU), FDA (USA), MHRA (UK)
Region: Europe
Compliance: FDA (cGMP), French Service-Public (CIR), EMA (EU GMP), MHRA (UK GMP)
Batch Size: Large, Small, Medium
Use: Human
BSL (Biological Safety Level): 1, 2
Services: Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Regulatory services, Packaging
Category / Product: BIOLOGICS
Chiny
ProBio CDMO | Biologics Platform
Probio
Globalne GCT i leki biologiczne CDMO, przyspieszające proces przejścia od genu do rynku komercyjnego.
Region: APAC
Compliance: FDA (cGMP), ISO, PMDA/MHLW (Japan GMP), EMA (EU GMP)
Batch Size: Large, Small, Medium
Use: Human
Category / Product: BIOLOGICS
Hiszpania
Cultiply
Cultiply
Hiszpańskie CDMO, które opracowuje procesy produkcji i oczyszczania rekombinowanych białek, enzymów, DNA i innych produktów pochodzenia biologicznego.
Markets: 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), CDSCO (India), TGA (Australia)
Region: Europe
Compliance: ISO
BSL (Biological Safety Level): 1, 2
Services: Development services, Manufacturing services
Controlled Substances: Lowest potential for abuse
Batch Size: Small, Medium
Category / Product: BIOLOGICS
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)
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