Our wide experience and flexible capabilities enable us to offer a tailored made suit with a short-lead time, from small to medium scale batches.
Rafa Sterile
We have leading capabilities of development and manufacturing of sterile products and controlled substances:
- Sterile and aseptic injectable liquids
- Formulations for combination devices (eg. Auto-injectors)
Pharmaceutical Commercial Manufacturing Services
- Bulk manufacturing: production of batches and transfer of methods including testing
- Flexible batches and a variety of production lines: solid, semi -solids, sterile production & liquids.
- Primary and secondary packaging: blisters, bottles, tubes, ampoules, cartridges, suppositories, serialization with aggregation
Pharmaceutical Quality and Regulatory Services
- International standards - Israeli GMP certificate (last qualified in July 2019), ISO 9001 approved. Rafa sterile manufacturing is approved by the FDA, EU (under ACAA agreement) , ANVISA and other regulatory agencies around the world
- Quality assurance
- Regulatory support including registration services and compliance. Expertise in Israel, EMA & FDA regulations
- Full QC including microbiology testing
- Qualified for controlled substances handling.
