Manufacturing Services

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.