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BIOLOGICS SERVICES in Europe
Biopharma Contract Packaging
Compliance
- ICH
- ISO
- EMA (EU GMP)
- FDA (cGMP)
- Health Canada (Canada GMP)
- ECOVADIS
- World Health Organization (GMP / HACCP)
- NMPA (China GMP)
- TGA (Australia GMP)
- ANVISA (Brazil B-GMP)
- Roszdravnadzor (Russia GMP)
- ANMAT (Argentina nueva GMP)
- MFDS/KFDA (Republic of Korea GMP)
- MHRA (UK GMP)
- UAE Ministry of Health & Prevention
- SFDA (Saudi Food & Drug Authority)
- TITCK (Turkish Health Authorities)
- 9001
- 13485 (Medical devices)
Activity
- Blood products / PDMPs, Abs (Antibodies), ADC & NDC (Antibody-drug), Peptide, protein, hormone & enzyme, Oligonucleotides, Vaccines, Human / animal extracted products, BIOLOGICS, SERVICES manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Phase I, Phase II, Phase III, Human, Veterinary
- Toxicity (OEB classification): N/A
- Controlled substance: N/A
- BSL: N/A
- Therapeutic areas: (A) Digestive tract and metabolism, (B) Blood and blood forming organs, (C) Cardiovascular system, (D) Dermatologicals, (G) Genito urinary system and sex hormones, (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, (P) Antiparasitic products, insecticides and repellents, (R) Respiratory system, (S) Sensory organs, (V06) Nutrients, (V04) Diagnostic agents, (V01) Allergens
- Markets: INVIMA (Colombia), FDA (USA), EMA (EU), CDSCO (India), Health Canada (Canada), MHRA (UK), TGA (Australia), NMPA (China), EDE (UAE), ANVISA (Brazil), ANMAT (Argentina), MFDS (South Korea), Russian Health Authorities, SFDA (Saudi Arabia), Turkish Health Authorities
Batch Size / Reactor
- Small, Medium, Large
Services
- Regulatory services, Quality Assurance services, Packaging, Logistics, Fill&Finish, Batch certification / release, GMP documentation, Secondary packaging, Labeling, Serialization, Storage, Distribution
