Compliance Remediation

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Summary: Expert solutions for addressing regulatory challenges, including Health Hazard Evaluations (HHE), risk assessments, Warning Letter/Form 483 responses (FDA and global agencies), CAPA development/authoring/execution, regulatory authority communication, and remediation of cGMP/cGLP/cGCP violations.

When regulatory issues arise, swift and effective remediation is crucial to minimize disruptions and maintain compliance. Regal Intel provides comprehensive compliance remediation services, offering expert guidance and support to address regulatory findings and ensure successful resolutions. We understand the complexities of regulatory enforcement and work diligently to help you navigate these challenges.

• We conduct thorough Health Hazard Evaluations and risk assessments to identify and evaluate potential risks associated with regulatory findings.
• Our experts assess the impact of non-compliance on product safety and patient health, providing a clear understanding of the necessary corrective actions.

• We provide expert assistance in analyzing and responding to FDA 483 observations and warning letters.
• Our team helps you understand the regulatory requirements and develop comprehensive remediation strategies.
• We assist in the remediation of all regulatory agencies including EMA, PMDA, TGA, NMPA, Anvisa and others.

• We assist in developing robust CAPA plans to address the root causes of regulatory findings and prevent recurrence.
• Our experts ensure CAPA plans are comprehensive, well-documented, and aligned with regulatory expectations.

• We provide expert guidance in authoring detailed CAPA plans, including timelines, responsibilities, and success metrics.
• We assist in the execution of CAPA plans, ensuring timely and effective implementation of corrective actions.

• We assist in developing robust CAPA plans to address the root causes of regulatory findings and prevent recurrence.
• Our experts ensure CAPA plans are comprehensive, well-documented, and aligned with regulatory expectations.

• We facilitate clear and effective communication with regulatory authorities, ensuring transparency and collaboration.
• Our team helps you prepare and submit comprehensive responses and documentation to close out warning letters and achieve regulatory compliance.
• We can assist with any required meetings with the regulatory agencies.

We can assist with the remediation of:

• Good Manufacturing Practices violations.
• Good Laboratory Practices violations.
• Good Clinical Practices violations.

• Expert Guidance: Our team comprises experienced regulatory professionals with a proven track record of successful remediation.
• Comprehensive Solutions: We provide end-to-end support, from initial assessment to final closeout.
• Proactive Approach: We help you anticipate and address potential compliance issues, minimizing disruptions.
• Clear Communication: We facilitate clear and effective communication with regulatory authorities.
• Global Regulatory Knowledge: We have expertise in a wide range of global regulatory requirements.