cGMP GTP GLP Consulting
The American College of Regenerative Medicine experts have 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
Assistance with FDA Inspections
Assistance in Preparing FDA Post-Inspection Response Documents
cGMP Document Drafting, Review and Editing Services
Implementing Training Programs
Quality Systems SOP Writing
Analytical Methods SOP Writing
Raw Material Qualification
Equipment Validation and Maintenance
The skilled and experienced team at The American College of Regenerative Medicine 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. We are your partner for performing successful leading-edge research.