AF Consulting Group, Inc.

 

 

Regulatory Compliance / Quality Systems NDA Review CMC Analysis
eCTD Build
CMC Change Control Management
Quality Systems Implementation
Pre-Approval Inspection Readiness
GXP Audit
Change Control
Investigations
In-Process Audits
Batch Record Review
Complaint System
Annual Product Reports
Standard Operating Procedures
GAP Analysis / Remediation Plans CAPA
Regulatory Enforcement
Specifications Harmonization
Training Development / Coordination
Validation Validation / Commissioning Master Plans
Equipment Qualification (IQ, OQ, PQ)
Facility & Equipment Commissioning
Cleaning, Sanitization & Sterilization
Process Validation
System Feasibility Studies
Process Troubleshooting
Laboratory System Qualification
System Change / Modifications
Project Management Process Engineering / Environmental Product & Process Transfer
New Product Launch Support
Process Troubleshooting
Facilities & Process Start-Ups
Process Optimization
Operational Excellence Implementation
Statistical Process Control
Operator’s / Engineer’s Training
Project Management
Hazardous Waste Management
Waste Cost Reduction
EPA Inspections / Permit
PR EQ Inspections / Permit
OSHA Process Safety
RCRA Compliance
Delta V Fundamentals
Wastewater Treatment
Capital Project Engineering
Risk Analysis