For more than 25 years, Lyophilization Technology, Inc. has built a focused reputation around pharmaceutical freeze-drying, serving more than 500 biotechnology and pharmaceutical organizations. The company helps clients move health-care products from early development into clinical use, with particular experience in aseptic clinical manufacturing for biologic and oncology products.
DEA Registration to Handle Controlled Substances
Registration
Current Good Manufacturing Practice (cGMP)
Compliance program
US and EU Regulatory Compliance
Compliance program
21 CFR Parts 210, 211, 600, and 820
Compliance program
ISO 5 / Class 100 HEPA Environment
Compliance program
USREGULATORYCOMPLIANCE
Quality certification
21CFRGMP
Quality certification