Regulatory Credentials

FDA Drug Registration

• Federal FDA registered Drug Establishment Clinical,Commercial and ANDA manufacturing
• California State Food and Drug Branch Licensed Drug Manufacturing Facility

European

MHRA GMP Certified

• Aseptic Small volume liquids
• Aseptic Semi-solids
• Aseptic Solids and implants
• Biotechnology products

FDA Device Registration

• IDE and PMA Products

European Device

• ISO 9001/2008 and ISO 13485/2003 certified