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About Lotus Consulting Group

Lotus Consulting Group has been in operation since March 2004 and provides comprehensive consulting and project management services in the fields of validation and quality assurance. Lotus Consulting Group serves both well established and start-up companies in the pharmaceutical, biotech, medical device and cosmetic industries. Our strong team leadership and experience base can support and accommodate the specific needs of our customers. Lotus Consulting Group offers experienced validation, compliance, and quality assurance services. We can assume full accountability and responsibility for your project or assist you with select project components of your choice. In working with you, we draw on a wealth of qualifications to implement your program from inception to completion. We use project documentation consistent with the applicable regulatory requirements. From our broad range of capabilities, we will align the right resources to the required program elements to guarantee the most favorable results and to suit your needs. SERVICES: • Validation Master Plans • Compliance Assessments • Validation Protocols / Reports • 21 CFR Part 11 Compliance • Validation Field Execution • EU / EC Compliance • Equipment Qualification • GAMP 4 Compliance • Utility System Validation • Quality System Action Plans • Facility Qualification • PAI Readiness Review • Computer System Validation • FDA / 483 / Warning Letter Responses • Cleaning Validation • Consent Decree / AIP Follow-up • Process Validation • Technology / Method Transfer • Gap Analysis • Calibration / PM Programs • Standard Operating Procedures • Data Tracking / Trending

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