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Description

Kaufman Flynn Consulting Services, LLC (KFCS) can guide you through the FDA compliance process: cGMP Systems, Validation, Submission, and Inspection. We work in multiple areas: Finished Dosage, Active Pharmaceutical, Ingredient (API), and Key Intermediate. Our performance is proven: over 30 years of successful FDA inspections and service in Asia, especially China. Our Services Design Qualification Review design of facility, equipment and system to make sure it meet both regulatory requirements, industry standards and your needs Qualification & Validation Guide you through equipment qualification, utility qualification, method validation, process validation, cleaning validation SOP Compliance Compliance with regulatory requirements and inspection trends, consistency of "SOP-Operation-Record" Quality Activities Deviation handling, change control, supplier qualification, risk management, etc. Training Project based training for your quality management people and technical / operation supervisors Submission Prepare and review ANDA, DMF, VMF Answer deficiency letters Inspection Handle inspection from regulated market authorities Respond to inspection observations, including Warning Letters Audit Audit manufacturing facilities based on your acceptance criteria