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, liquid, and lyophilized 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.)
-
Manufacturing of liquid and semi-solid formulations such as suspensions, emulsions, topical creams, foams, polymers, 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.