AssureImmune has broad experience and expertise in cGMP, GTP and GLP guidelines. As one of our strongest abilities, we build and assess your operations to assess regulatory compliance expectations of the cGMPs and offer recommendations on improvements required within regulatory compliance standards.

We offer following services:

• Designing Quality Systems
• Audits
• Assistance with FDA Inspections
• Assistance in Preparing FDA Post-Inspection Response Documents
• cGMP Document Drafting, Review and Editing Services
• Document Control
• cGMP Training
• Implementing Training Programs
• Process Validation
• Quality Systems SOP Writing
• Analytical Methods SOP Writing
• Risk Assessment
• Supplier Qualification
• Supplies Qualification
• Raw Material Qualification
• Equipment Validation and Maintenance

AssureImmune’s skilled and experienced team can assist with study conduct, data collection, and reporting following GLP guidelines.

The importance of following FDA regulatory guidelines is vital in research as consequences for noncompliance are severe. At AssureImmune, our regulatory knowledge is an essential component in performing successful leading-edge research.