Manufacturing Services

A custom manufacturing process for your unique product

Manufacturing for early stage clinical trials requires compliance with cGMP/ISO13485 but also flexibility, as the production process might still evolve during these stages.

We offer manufacturing services for semi-solid and liquid formulations (sterile and non-sterile products). Our experience with cGMP/ISO13485 manufacturing of Clinical Trial Material (CTM) is as diverse as our customers, ranging from fill-and-finish projects to complex, aseptic manufacturing processes. Finished products are tested in our QC laboratories to ensure that they meet the product's specifications at release and during shelf-life. The product is then approved for clinical trials by our pharmacist in charge/QP.

 

Using a flexible approach and creative thinking help us find simple solutions for complex developmental challenges that might arise during technology transfer, scale up, or clinical batches manufacturing.

Services for you

  • Drug and medical device manufacturing for Phase I-III studies in a GMP certified facility, according to FDA and EMEA requirements.

  • Aseptic manufacturing of sterile products in ISO 5 (class 100) cleanrooms (suitable for parenteral and ophthalmic solutions, topical creams for open wounds treatment, etc.)

 

 

  • Analytical and stability testing for the finished product.

 

  • Full QA/QC support and QP services.

  • Clinical labeling and packaging.

  • Planning and executing scale-up processes for formulations developed by the client or by us (including Technology transfer to and from Nextar).

 

  • Development and manufacturing of special drug delivery systems such as liposomes.

  • Preparation of Chemistry, Manufacturing, and Controls (CMC) supporting documentation for submission to regulatory agencies.

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