Quality Assurance Services

At RCS, we offer comprehensive Clinical Quality Assurance (CQA) services to ensure the highest standards of compliance and quality for clinical trials across all phases (I-IV). Our team brings a wealth of expertise in global regulatory frameworks, including US-FDA, EMA, and MHRA, with a proven track record in GCP compliance and successful navigation of regulatory audits worldwide. No matter the product or therapeutic area, we deliver excellence and maintain unwavering adherence to regulatory requirements to support the success of your clinical programs.

Key Highlights

• Robust Quality Management Systems (QMS)

• 10 Years of Clinical Quality Assurance Expertise

• Global Regulatory Compliance

• ISO 9001:2015 and ISO 14155:2020 Certified

• End-to-End Compliance Monitoring

• Comprehensive QA Services

• Audit Readiness and Support

• Global Reach

• Expert Guidance on Compliance and Best Practices

• Risk Management and Mitigation

At RCS, our Independent Quality Assurance unit is dedicated to delivering best-in-class quality assurance, ensuring compliance and supporting clinical trials that lead to market approvals.

Our mission is to improve lives through transformative clinical research by upholding the highest standards of quality and regulatory compliance

Regulatory  Compliance

Our quality assurance and control practices ensure adherence to all relevant regulations and guidelines. This not only upholds the integrity of our research but also facilitates smooth and successful interactions with regulatory agencies.

Clinical Trial Efficiency

Our quality assurance protocols help identify and address potential issues early in the research process, reducing costs and accelerating the development of new treatments and therapies.

Data Integrity

Our rigorous quality assurance and control processes ensure that all collected data is valid, reliable, and consistent with established protocols. This commitment to data integrity underpins the trustworthiness and validity of our clinical studies.

Research Subjects

Our quality assurance measures ensure that all clinical research is conducted ethically, By prioritising subject safety, we mitigate risks such as physical and psychological harm, loss of confidentiality, and exploitation.

Quality Objective

Key Features of Our Quality Assurance Team

Highly Trained Team

Extensively trained on quality and regulatory compliance, as well as global standard operating procedures. We ensure that our team is well-equipped to anticipate and comply with regional or local regulatory requirements, providing consistent, high-quality services across the globe.

Robust (QMS)

Our robust and harmonized Quality Management System (QMS) ensures that everyone on your project team adheres to the same high standards of quality. We prioritize compliance and quality assurance in every aspect of our operations, from project initiation to completion.

Global Expertise

Our deeply experienced global QA team brings over 10 years of experience in strategically preparing for, hosting, managing, and closing out regulatory inspections for our clients. We support dozens of client audits annually with minimal to no findings, including inspections from regulatory bodies such as DCGI, MHRA, US-FDA.

Quality Assurance Services

QMS Development Service

We design and implement robust Quality Management Systems (QMS) tailored to your organization's needs, ensuring compliance with ISO 9001:2015 and GxP standards. Our QMS solutions drive continuous improvement, risk management, and regulatory adherence across all clinical operations.

Regulatory inspection readiness and response

Our team prepares your sites and teams for regulatory inspections, ensuring full compliance with global standards. We provide expert support in responding to regulatory authority queries, mitigating risks, and ensuring smooth audit outcomes.

Investigational site audits

We conduct comprehensive investigational site audits to verify adherence to GCP, protocol compliance, and data integrity. Our audits ensure that investigational sites meet the highest ethical and regulatory standards, ensuring successful trial outcomes.

GxP Audits

We provide full-spectrum GxP (Good Clinical, Manufacturing, and Laboratory Practices) audits to ensure your operations comply with global regulatory guidelines. Our GxP audits safeguard product quality, patient safety, and data integrity across all trial phases.

                  Vendor/Supplier Audits

Our vendor and supplier audits assess the quality, compliance, and reliability of your partners, ensuring they meet regulatory requirements. We provide actionable insights to mitigate risks and maintain a high standard of quality throughout your supply chain.

Quality Event Management Services

We offer end-to-end management of quality events, including deviations, non-conformances, and CAPAs. Our team ensures rapid identification, investigation, and resolution of quality issues, preventing compliance gaps and safeguarding trial integrity.

Ready to elevate your clinical research with our Quality Assurance services?

Contact us today to learn more about how RCS can support your quality assurance needs and help you achieve your research goals.

• Commitment to Excellence: We are dedicated to delivering elevated quality assurance services that meet and exceed regulatory requirements and industry standards.

• Global Reach: With a global presence and expertise, we offer consistent, high-quality services across diverse geographic regions and regulatory environments.

• Experience and Expertise: Our deeply experienced QA team brings decades of collective experience in supporting clinical trials and regulatory inspections, ensuring the success of your projects.

• Continuous Improvement: We continuously explore ways to improve processes and standards, proactively addressing quality issues and implementing robust corrective and preventive actions.

What Makes us Unique