ابحث واعثر على CMO / CDMO الذي تحتاجه

Markets: Turkish Health Authorities, ANVISA (Brazil), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), MHRA (UK)

Batch Size: Small, Medium, Large

Category / Product: FDF / DRUG PRODUCTS, SERVICES

Compliance: Roszdravnadzor (Russia GMP), EMA (EU GMP), UAE Ministry of Health & Prevention, ANVISA (Brazil), TGA (Australia GMP), NMPA (China GMP), ECOVADIS, ISO, Health Canada (Canada GMP)

Region: Europe

Use: Human

Services: Analytical / QC services, Manufacturing 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)

Controlled Substances: High potential for abuse & medical use

Batch Size: Medium, Large

Category / Product: FDF / DRUG PRODUCTS, NUTRACEUTICALS

Compliance: EMA (EU GMP), ISO

Region: Europe

Use: Veterinary

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

Markets: EMA (EU)

Batch Size: Medium, Large

Category / Product: FDF / DRUG PRODUCTS, NUTRACEUTICALS

Compliance: Roszdravnadzor (Russia GMP), EMA (EU GMP), ANVISA (Brazil B-GMP), TGA (Australia GMP), FDA (cGMP), Health Canada (Canada GMP)

Region: Europe

Markets: ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU), TGA (Australia), Health Canada (Canada)

Use: Human, Veterinary

Services: Analytical / QC services, 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)

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

Batch Size: Small, Medium, Large

Category / Product: FDF / DRUG PRODUCTS, NUTRACEUTICALS

Compliance: Roszdravnadzor (Russia GMP), ANVISA (Brazil B-GMP), World Health Organization (GMP / HACCP), FDA (cGMP), ISO, MFDS/KFDA (Republic of Korea GMP)

Region: Europe

Use: Human

Services: Analytical / QC services, 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)

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

Batch Size: Small, Medium, Large

Category / Product: FDF / DRUG PRODUCTS, COSMETICS, PARTICLE ENGINEERING, NUTRACEUTICALS

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

Region: Europe

Use: Human, Veterinary

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

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

Markets: Turkish Health Authorities, ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU), MFDS (South Korea)

Batch Size: Small, Medium, Large

Category / Product: FDF / DRUG PRODUCTS

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

Region: Europe

Use: Human, Veterinary

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

Therapeutic Areas of Expertise (ATC): (H) Systemic hormonal preparations excl. sex hormones and insulins

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

Batch Size: Small, Medium, Large

Category / Product: FDF / DRUG PRODUCTS, NUTRACEUTICALS

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

Controlled Substances: Lowest potential for abuse, High potential for abuse & no medical use, High potential for abuse & medical use, Lower potential for abuse, Low potential for abuse

Region: Europe

Markets: ANVISA (Brazil), FDA (USA), Russian Health Authorities, EMA (EU)

Use: Human

Services: Analytical / QC services, 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)

Batch Size: Small, Medium, Large

Category / Product: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING, NUTRACEUTICALS

Compliance: EMA (EU GMP), PMDA/MHLW (Japan GMP), SFDA (Saudi Food & Drug Authority), ISO, MFDS/KFDA (Republic of Korea GMP)

Region: Europe

Use: Human, Veterinary

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

Markets: PMDA (Japan), EMA (EU), MFDS (South Korea), SFDA (Saudi Arabia)

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)

Batch Size: Small, Medium, Large

Category / Product: FDF / DRUG PRODUCTS

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

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

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)

Batch Size: Small, Medium, Large

Category / Product: FDF / DRUG PRODUCTS, COSMETICS, NUTRACEUTICALS

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

Region: Europe

Use: Human, Veterinary

Services: Analytical / QC services, Logistics, Manufacturing 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)

Markets: FDA (USA), EMA (EU)

Markets: DIGEMID (Peru), ANMAT (Argentina), Turkish Health Authorities, EDE (UAE), بقية العالم, ANVISA (Brazil), ISP (Chile), PMDA (Japan), FDA (USA), MSPAS (Guatemala), CDSCO (India), Russian Health Authorities, EMA (EU), COFEPRIS (Mexico), MFDS (South Korea), SFDA (Saudi Arabia), TGA (Australia), NMPA (China), Health Canada (Canada), INVIMA (Colombia), MHRA (UK)

Batch Size: Small, Medium

Category / Product: FDF / DRUG PRODUCTS

Region: Europe

Use: Human

Compliance: MHRA (UK GMP), ECOVADIS

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

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

Therapeutic Areas of Expertise (ATC): (M) Musculoskeletal system, (G) Genito urinary system and sex hormones, (C) Cardiovascular system, (A) Digestive tract and metabolism, (D) Dermatologicals, (N) Nervous system, (B) Blood and blood forming organs

Batch Size: Small, Medium, Large

Category / Product: FDF / DRUG PRODUCTS, PARTICLE ENGINEERING

Compliance: EMA (EU GMP), FDA (cGMP), ISO

Region: Europe

Use: Human

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

Markets: FDA (USA), EMA (EU)

Therapeutic Areas of Expertise (ATC): (V01) Allergens, (S) Sensory organs

BSL (Biological Safety Level): 1

OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 5,000 µg/day)