Our due diligence audits provide a comprehensive assessment of the regulatory and operational readiness of potential partners, suppliers, and facilities. We evaluate compliance with FDA Standards, to identify risks and verify effectiveness of existing quality system. Whether preparing for mergers, acquisitions, or strategic partnerships, our audits offer actional insights to support sound business decisions and long-term success.

Our mock audits simulate real FDA and regulatory body inspections to identify potential compliance gaps. Covering manufacturing processes, quality management systems, and clinical trial operations, these audits prepare you for upcoming inspections, minimizing risks and avoiding costly delays. By engaging our experts, you gain actionable insights, practical solutions, and tailored recommendations to strengthen your regulatory preparedness.

We specialize in creating robust quality management systems aligned with FDA and international standards. Our approach ensures compliance and operational excellence by integrating quality controls throughout the process. From establishing governance models to monitoring systems, we help you embed sustainable quality into every process, mitigating risks and securing regulatory approval.

We help companies develop robust GxP strategies, ensureing compliance with FDA and international regulations across product lifecycles. Our services span GMP, GLP, GCP, focusing on operation integrity, product quality, and regulatory approval. Whether you’re launching a new product, optimizing existing operations, or remediating, we ensure your processes meet the highest standards.

We offer comprehensive remediation services to address regulatory compliance issues, including FDA warning letters, 483 observations, Import Alerts, and other audit findings. Our experts perform Baseline Audits, develop corrective and preventive action plans (CAPA), help revise systems and procedures, and guide you through the remediation process to align operations with regulatory standards, restoring compliance efficiently and sustainably.

Our tailored training programs keep your team current with evolving regulatory standards and compliance practices. We offer practical mentoring to build in-house expertise, fostering a culture of continuous improvement and compliance excellence. Whether training staff on GxP, or quality management systems, our programs empower your organization to maintain operational and regulatory requirements.