REGION: Europe
KATEGORIE/PRODUKT: OLIGONUKLEOTIDE, FDF / DRUG PRODUCTS, CHEMICAL-SYNTHETIC, KOSMETIK, SERVICES
VERWENDUNG: Menschlich
COMPLIANCE: FDA (cGMP), PMDA/MHLW (Japan GMP), ANVISA (Brazil B-GMP), ISO, EMA (EU-GMP), Französischer Dienst - öffentlich (CIR), ECOVADIS, Weltgesundheitsorganisation (GMP / HACCP), MHRA (UK GMP), NMPA (China GMP), TGA (Australia GMP), Roszdravnadzor (Russia GMP), ANMAT (Argentinien neue GMP), MFDS/KFDA (Republik Korea GMP), ISP (Chile BPM), INVIMA, MSPAS, COFEPRIS, DIGEMID, Gesundheit Kanada (Kanada GMP)
DIENSTLEISTUNGEN: Development services, Manufacturing services, Analytical / QC services, Regulatory services, Packaging, Logistics, Quality Assurance services
BATCH-GRÖSSE: Klein, Groß, Mittel
MÄRKTE: FDA (USA), EMA (EU), PMDA (Japan), ANVISA (Brazil), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, DIGEMID (Peru), COFEPRIS (Mexico), INVIMA (Colombia), MSPAS (Guatemala), ISP (Chile), EDE (UAE)
THERAPEUTISCHE FACHGEBIETE (ATC): (D) Dermatologicals, (A) Digestive tract and metabolism, (C) Cardiovascular system, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (G) Genito urinary system and sex hormones
OEB (Occupational Exposure Banding): 1 / low-hazard (PDE > 10,000 µg/day)
