FDA Product Approval Services

FAR Chemical offers a range of pharmaceutical services including but not limited to:

• International product registration
• Conducting due diligence audits
• Providing consulting services related to FDA pharmaceutical policies and procedures
• Interpreting FDA policy and guidance documents related to cGMPs
• Reviewing laboratories for compliance with GMP requirements
• Providing recall advice and assistance
• Preparing SOPs for complaint handling, recalls, change control, employee practices, failure investigations, etc.
• Preparing companies for FDA pre-approval inspections by conducting “FDA-like mock inspections”
• Reviewing Chemistry and Manufacturing Control (CMC) submissions to FDA
• Six Sigma process improvement strategies and statistical modeling