We conduct gap analyses and develop corrective action plans, ensuring end-to-end preparedness. Our mock inspections mimic regulatory ones, helping staff practice proper response protocols and document handling effectively.
We provide regulatory strategy development, quality management system design, clinical development planning, and vendor selection. Our services guide start-ups for optimized growth, regulatory milestone achievement, and compliance framework implementation tailored to specific project needs.
Our vendor audits evaluate CROs and laboratories for quality and regulatory compliance. This includes scrutinizing processes, documentation, and adherence to industry standards to mitigate risk and improve trial outcomes.
Our pricing is customized based on individual service needs. This approach allows us to offer cost-effective solutions tailored to specific project requirements, ensuring optimal resource utilization and value for each client engagement.
We utilize secure digital platforms and video conferencing to conduct virtual assessments, ensuring comprehensive review of clinical trial processes and documentation for continuous compliance, regardless of location.
Our inspection readiness service ensures regulatory compliance by conducting thorough document evaluations, staff training, and action planning. This reduces non-compliance risks, enhancing preparedness for FDA or EMA inspections, and ensuring trials meet all necessary standards.
Our consulting emphasizes ongoing oversight through developing internal audit programs and compliance frameworks. This proactive approach identifies and resolves issues, ensuring ethical and regulatory alignment throughout the clinical research lifecycle.
QA professionals bring specialized knowledge of current regulatory requirements, extensive experience with FDA and international regulatory expectations, understanding of industry best practices across multiple therapeutic areas, expertise in risk-based approaches to quality management, and objective perspective uninfluenced by internal pressures or timelines.