QUALITY MATTERS: ISO COMPLIANCE, INSPECTION READINESS, AND GXP AUDITS

Model: Full-service CRO capabilities, FSP or insourcing

Category: *CRO

Exhibitor: SUPERNOVA CLINICAL RESEARCH, INC.

Booth No: M724

Characteristic

At SuperNOVA, quality is our primary mission. We believe that quality involves expertise, dedication, vigilance, and a solid organizational foundation. We are committed to providing comprehensive solutions to support your organization in achieving ISO compliance, inspection readiness, and conducting GxP audits. Our experienced team of regulatory and quality assurance professionals is dedicated to helping you navigate regulatory requirements, identify areas for improvement, and maintain compliance with industry standards while upholding the highest standards of quality.

ISO Compliance
Conforming to ISO standards is essential for organizations operating in various industries, including healthcare and life sciences. Our team of experts specializes in helping organizations achieve ISO compliance, particularly ISO 9001 (Quality Management System) and ISO 13485 (Medical Devices – Quality Management System).

Inspection Readiness
Being prepared for regulatory inspections is crucial for maintaining compliance with regulatory requirements and ensuring a smooth inspection process. Our inspection readiness services aim to optimize your organization’s readiness for inspections by conducting comprehensive mock inspections, evaluating compliance gaps, and providing guidance on corrective actions. We help you establish robust inspection processes, develop effective documentation systems, and train your staff to ensure readiness for regulatory inspections.

GxP Audits
GxP audits are essential for ensuring compliance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) regulations. Our experienced auditors conduct comprehensive GxP audits, evaluating your organization’s compliance with applicable regulations and guidelines. We identify areas of non-compliance, provide recommendations for improvement, and assist in implementing corrective actions.

Quality Infrastructure
We believe that quality involves expertise, dedication, vigilance, and a solid organizational foundation. Our team at SuperNOVA embodies these principles, ensuring that every team member, process, and procedure reflects our commitment to excellence.