Poland Europe
FDF / DRUG PRODUCTS BIOLOGICS in Europe
mRNA & LNP manufacturing, F&F
Certifications
- ISO
- EMA (EU GMP)
Activity
- ATMP (Advanced Therapies), Injectables, Terminal sterilization, Fill&Finish, Small volume vials, Large volume vials / Bottles, PFS (Prefilled Syringes), Cartridges, FDF / DRUG PRODUCTS, BIOLOGICS manufacturing
Features
- Uses: Investigational, Commercial (Phase IV), Preclinical, Phase I, Phase II, Phase III, Human, Veterinary
- Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day)
- DEA: N/A
- BSL: 1
- Therapeutic areas: N/A
- Markets: FDA (USA), EMA (EU), PMDA (Japan)
Batch Size / Reactor
- Small, Medium, Large, Batch, 1 - 100 L, 100 - 1000 L
Services
- Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Preformulation studies, R&D, Formulation / Galenic design, QbD (Quality by Design), Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, Downstream, Fill&Finish, Sterile product manufacturing, Non sterile product manufacturing, Upstream, Tech transfer, Pilot plant, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Bioanalysis, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, CMC regulatory support, IND (Investigational New Drug aplication) filing support, IMPD (Investigational Medicinal Product Dossier) submission support, NDA (New Drug Application) submission support, CTD/eCTD compilation and submission, DMF (Drug Master File) preparation and submission, Orphan Drug Designation Support
