Services Offered by $GATA:
Analytical QC
QA Functions
Readiness for Inspections
Compliance
Validation
Clinical Trial Management
Regulatory/Legal
Preparation of Regulatory Filings (IND's/PMA's/NDA's/ANDA's/510Ks etc)
Compliance Assessments (GLP, GMP, GXP)
Risk Assessments
Mock FDA Audits
Medical Device Support
CMC Support
GMP Training
Facility Layout Consulting
Utilities, Process, IT, Computer, and Cleaning Validation
Training