CFRA Associates 

Quality Audit & Compliance Consultation

Maintaining high-quality standards and ensuring compliance with regulations is vital for the success and reputation of your organization. Our quality audit and compliance services help identify gaps, mitigate risks, and improve your quality management systems. We conduct comprehensive audits, assess compliance with regulatory requirements, develop corrective action plans, and provide ongoing support to optimize your quality processes. 

• We assist in the implementation of quality management systems ISO 13485:2016, Quality System regulations 21 CFR 820 by assisting in preparing Standard Operating Procedures, Quality Manuals, Quality Policies, Device Master Files, Device History Records, training,  Risk Management, Gap analysis, Corrective and Preventive Action, CE marking and UKCA certifications, and all other formats/records for medical devices. 

• We assist in the implementation of Quality Management systems ISO 9001, current Good Manufacturing Practices 21 CFR 210 & 211 by preparing Standard Operating Procedures, Quality Manuals, Quality Policies, Master Manufacturing records,  Batch Processing and Packing Records, cGMP/GLP training,  Risk Management, Gap analysis, Corrective and Preventive Action and all other formats and records for drugs and biologicals. 

• Our Expert team will assist in the implementation of Quality Management Systems, Environmental Management Systems, Current Good Manufacturing Practices, and Good Laboratory Practices to obtain ISO, WHO GMP, US FDA, UK  MHRA, and TGA, etc.,