GCP Consulting

Efficiency and quality go hand in hand. We’ll assess and refine your processes, optimizing them for maximum productivity and compliance.

A well-informed team is a compliant team. We’ll help you design and implement training programs that empower your personnel with the knowledge and skills needed for top-notch performance.

In the event of non-compliance, we’re your crisis management experts. We’ll swiftly identify issues, help you implement corrective and preventive actions, and fortify your defenses against future breaches.

In a landscape governed by ever-evolving regulations, proactive risk assessment and mitigation are indispensable. Our experts will conduct thorough risk assessments tailored to your specific operations. We’ll identify potential pitfalls, vulnerabilities, and compliance risks. Once the risks are pinpointed, we’ll collaborate with your team to design robust mitigation strategies. This process ensures you’re not merely reacting to problems but actively preventing them, safeguarding your compliance journey.

Effective documentation and record-keeping are the bedrock of compliance. We’ll thoroughly review your documentation processes, ensuring they meet the rigorous demands of ICH GCP E6(R2) and ISO 14155:2020. From study protocols to adverse event reporting, we’ll leave no document unexamined. Our guidance will streamline your documentation practices, minimizing errors, enhancing traceability, and fortifying your compliance posture.

Audits and inspections can be nerve-wracking experiences without proper preparation. Our services include rigorous audit readiness preparation. We’ll simulate audit scenarios, conduct mock inspections, and equip your team with the skills needed to confidently face regulatory requirements. With our guidance, you’ll not only survive inspections but also thrive in them, showcasing your commitment to compliance.

In today’s interconnected world, managing vendors is a critical part of quality compliance and Sponsor oversight. We’ll assess your vendor relationships, evaluating their impact on your quality management. Our expertise will help you establish robust vendor management practices, ensuring that the quality of products and services you receive meets your standards and regulatory requirements.