Manufacturing & Packaging


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Home Page ס Manufacturing & Packaging ס Sterile & non sterile

Sterile and non sterile

 

Nextar's team has carried out over 750 projects for about 

140 clients. Hence, working under cGMP regulatory standards, we provide experienced, cost effective, flexible and reliable support for your pre clinical and Clinical Trial Material (CTM) supplies. Our projects are as diverse as our customers, ranging from simple fill and finish to complex, aseptic manufacturing projects, all under the same roof.

Since our inception in 2007, we have gained significant knowledge and expertise in the fields of pharmaceutical manufacturing. Our tech transfer officers try to ensure a smooth interface between early developmental activities and our formulation, analytical and production facilities.

We offer production of CTM (both drugs and medical devices) using full service cGMP- compliance 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) through Phase III clinical trials. 


Our cGMP services:
 

  • Technology transfer to and from Nextar to scale up production
  • Raw materials release
  • CTM manufacturing for Phase I-III studies according to FDA and EMEA requirements
  • Sterile manufacturing of parenteral drugs in ISO 5 (class 100) clean rooms 
  • Developemnt and manufacturing of special drug delivery systems such as liposomes
  • Manufacturing of suspensions, emulsions, topical creams, foams,   polymers etc
  • Validation of aseptic filling into vials, syringes or dropper bottles
  • Clinical packaging and logistics, primary and secondary packaging
  • Blinding of study materials and comparators
  • Preparation of Chemistry, Manufacturing and Controls (CMC) supporting documentation for submission to regulatory agencies
  • Full QA/QC support

 

Our experienced team will develop your product in an effective and efficient manner