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a new CDMO with 3 sites, located in Burgundy, France
Site is offering a wide range of manufacturing capabilities, with a strong focus on solid doses, powder sachet filling and a dedicated high potent drugs facility.
Site is specialized in LYOC - Lyophilized freeze dried tablets (ODT).
Site is offering capacities in Blister Packaging, QC, Stability Studies, and a wide range of pharmaceutical services from Analytical Development & validation to Graphic Art services, Scientific and Regulatory services.
Products from galien+
Galien LPS offers services includes analytical services. It has ich storage capacities, monitored in temperature and humidity 24 hours a day; analyzes of raw materials and finished products; optimization and modernization of methods, hplc to uplc transposition; validation: reports, trend analysis. Contact us for more information.
Method Development and validation
European testing & batch certification
Artworks development in GMP Studio:
Creation of printed packaging materials: leaflets, aluminum, foils, folding boxes
Change coordination with customers and printers
Team of Experienced DTP* designers specialized in Pharmaceutical industry & trained to GMP and regulatory requirements
galien+ Never site is specialized in oro-dispersible forms obtained by freeze-drying process known under LYOC® brand.Nevers site also exports its expertise in Africa and Middle East markets.
What is LYOC ?
The LYOC® is a porous solution containing an active ingredient dispersed in an alveolar structure.
Very hydrophilic , it dissolves and disperses instantly in the mouth on contact with saliva.
The LYOC® can be taken directly into the mouth without additional water addition. The oral lyophilisate retains all the properties of the original liquid preparation.
Lyophilization is a freeze drying process e.g. a drying of a previously frozen aqueous or organic system. LYOC® technology may concern all the active ingredients and all prescription or OTC drugs, but also veterinary products
Galien LPS offers services includes packaging service. It has a great know-how and expertise in dry forms packaging. 6 dedicated medium speed lines, in closed, humidity and temperature controlled rooms. Different kinds of tablets, hard and soft capsules are therefore packaged in sens plant workshops. Automated systems at each stage of the production chain. Contact us for more information.
galien+ Sens unit has a great know-how and expertise in dry forms packaging.
6 dedicated medium speed lines, in closed, humidity and temperature controlled rooms allow packaging different solid forms.
Different kinds of tablets, hard and soft capsules are thus packaged in Sens plant workshops.
Automated systems check at each stage the use good packaging item all throughout the production chain. Sensors linked to an application also provide real-time information on line efficiency, OEE, allowing us to determine precisely root causes of machine stops, make adjustments and adapt the maintenance program as necessary.
From late 2018, galien+ Sens unit will offer to its customers serialization and safety features on all its packaging lines as required by European Falsified Medecines Directive.
Technical and Scientific supports
Technical writing of Dossiers and variations
Post marketing authorization maintenance support Services
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