Development & Manufacturing Services

Rafa - The First Israeli End-to-End CDMO

We pride ourselves on being the first Israeli CDMO offering end-to-end services from product development to commercial manufacturing. 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 for both fabless and established pharma customers.

As one of the leading Israeli pharmaceutical companies, and as an ally of Israel's innovative biopharma companies, we understand their challenges and unmet needs and offer them a wide range of development and manufacturing services, "under the same roof" and closeby - in Israel!

We look forward to help Israeli biopharma companies shorten time to market their innovative drugs, and to contribute to the efforts of making Israel a leading global center for health sciences innovation.

Rafa – Israel's Leading Sterile CDMO

We are the only pharmaceutical company in Israel with both development and commercial capabilities to handle sterile products.

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 Product Development Services

  • Early stage program: Delivery of cGMP and non-cGMP batches and delivery of clinical trial batches
  • Scale up program & quality by design: Scale up to commercial scale manufacturing
  • Tech Transfer: Method transfer of all stages from development to production and finished product testing

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, FDA  Approved, EU Approved, Accreditations from The TGA (Australia), KFDA (Korea), ANVISA (Brazil) and other global health authorities.
     ISO 9001 approved
  • 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

Our Experienced Teams

Our professional teams are well experienced in providing development and manufacturing services to fabless developing pharma companies, through large multinational pharmaceutical companies and big governmental organizations. Our dedicated project teams ensure continuity as products progress through all stages and co-operation with the customer to overcome unexpected challenges throughout the process.

 

Rafa CDMO - An outsource service with a DNA of an innovative company and international standards located in Israel

We welcome you to contact us and allow our experts the opportunity to understand your needs and propose tailor-made solutions to promote your success.

Please send an email to : ronenc@rafa.co.il