Alvotech ef Biosimilars Project, Iceland

• Facilities for the development of clinical and commercial products to meet FDA and EMA GMP requirements
• Project management and strategy support
• GMP compliance consultancy
• Generation of numerous equipment specifications and user requirement specs and support to procurement
• Design, equipment engineering, FAT and SAT oversight for larger packages including autoclaves, large VPHP chambers and sterility test isolator
• Process engineering support, mass balance development, PFD development and evaluation of options through project life cycle 
• Area 13,000m² support 2015 – 2016.