A strong Clinical Quality Assurance (CQA) framework is essential for maintaining the integrity, reliability, and compliance of clinical programs. Our CQA services provide proactive to reactive quality support to sponsors and CROs, ensuring adherence to regulatory standards and industry best practices. Ensure Clinical Quality & Compliance with Expert Support.
Oversight and compliance support for CROs, investigator sites, central labs, pharmacies, animal/toxicology studies, SaaS providers, and other vendors to ensure regulatory adherence and performance.
Identifying and resolving clinical trial issues to mitigate risks and improve study outcomes.
Thorough assessments of Trial Master Files to ensure completeness, accuracy, and regulatory compliance.
Tailored support to address specific clinical quality challenges and operational needs.
A structured auditing approach is essential for identifying compliance gaps, mitigating risks, and ensuring regulatory readiness. Our clinical auditing services help organizations maintain compliance with global regulatory expectations.
Regulatory inspections can be complex and high-stakes. Our inspection readiness services ensure your organization is fully prepared to meet global regulatory expectations with confidence.
Evaluating your current QMS and scaling solutions to fit your organization’s size, scope, and regulatory requirements.
Creating and refining policies, SOPs, and quality documents to ensure compliance with industry standards.
Supporting the seamless integration of quality management systems across your operations.
Providing in-depth training on QMS best practices, regulatory expectations, and continuous improvement strategies.
Whether you're building a new QMS or enhancing an existing system, our experts provide tailored solutions to ensure compliance and efficiency.
At ProPharma, we provide expert clinical consulting services to medical device and diagnostics companies. Helping to navigate and ensure compliance to complex global regulatory requirements while achieving operational excellence.
Our team specializes in supporting the unique requirements of medical device companies in meeting international compliance standards, including:
February 19, 2026
Learn why Medical Information is essential for MAH compliance, patient safety, and capturing reportable data, ensuring trust and proactive insights in real-world medical use.
February 12, 2026
Discover why centralizing Medical Information functions ensures consistency, improves efficiency, and balances global standards with local needs in the healthcare industry.
February 2, 2026
Explore how AI is transforming pharmacovigilance while ensuring patient safety, data integrity, and regulatory compliance with insights from the 2025 CIOMS report.
January 27, 2026
ProPharma’s greenhouse gas reduction targets are validated by SBTi, aligning with the Net-Zero Standard and a commitment to reach net-zero by 2050.
December 11, 2025
ProPharma expands with a new office in Hyderabad, enhancing innovation and growth in regulatory, clinical, and compliance services for the life sciences industry.
December 4, 2025
ProPharma taps Daniel Ryan as President of Clinical Research Solutions, strengthening its clinical trial management leadership and expanding its FSP Solutions.
