Working under cGMP regulatory standards, we provide expert, cost effective, flexible and reliable one stop shop support for your clinical trial material (CTM) supplies and needs in our cGMP manufacturing facilities and Quality Control laboratories approved by Israel Ministry of Health.

We offer production of CTM for all phases of drug development with full service cGMP-compliant procedures and state-of-the-art equipment. Our clinical supply chain strategy, packaging and logistics support provides solutions for all types of clinical trial programs covering first-time-in human studies (Phase I), proof-of-concept studies, through Phase IV trials.

All procedures are professionally managed and maintained to the highest standards, conforming to cGMP guidelines, our experienced team will advise you on your clinical trial material, labels and packaging ensuring that you will meet your study timelines.

Our cGMP contract manufacturing services include:

• CTM manufacturing for US and EU clinical trials according to FDA and EMEA standards.
• CTM production for Phase I-IV studies.
• Full CTM formulation, manufacturing, packaging and QC release testing.
• Manufacturing of all types of dosage forms: parenteral solutions, lyophilized sterile products,ophthalmic drops, suspensions, emulsions, topical creams, capsules and tablets.
• Sterile manufacturing of injectables and lyophilized powders in Class 100 clean rooms (ISO 5)
• Validation of aseptic filling into vials, syringes or dropper bottles.
• Clinical packaging and logistics, primary and secondary packaging.
• Blindind of study materials and comparators. Placebo manufacturing.
• Help in sourcing suppliers and release of raw materials and active ingredients (API) according to Pharmacopeal monographs.
• Contract manufacturing of small and medium batches for commercial use.
• Technology transfer for scale up production.
• Preparation of CMC supporting documentation for submission to regulatory agencies / Full QA/QC support