Working to both USA (FDA) and Global (ICH) standards, Cytotech Labs offers expert, cost-effective, flexible and reliable support for your clinical supplies needs. Services include:

• Manage the entire process from manufacturing to electronic filing
• Provide temperature-controlled storage facilities for stability studies
• Develop Placebo formulations and  produce clinical supplies for Blinded-studies
• Regulatory support for submission of IND, NDA, ANDA
• Small to large scale GMP manufacturing for Phase I to Phase IV protocols
• Development of placebos for blinded studies
• Identification and optimization of packaging materials
• Monitored storage facilities for both raw materials and finished product
• Packaging, labeling and randomization of study materials
• Stability storage and expiration dating