January 29, 2026
Preparing for eCTD 4.0: What FDA Submitters Need to Know
eCTD 4.0 is coming. Learn what’s changing, why early planning matters, and how FDA submitters can prepare for a smooth transition.
Clinical Quality Assurance
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.
Our Clinical Quality Assurance Solutions
Vendor Management & Compliance
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.
Clinical Investigation & Remediation
Identifying and resolving clinical trial issues to mitigate risks and improve study outcomes.
TMF/eTMF Compliance Reviews
Thorough assessments of Trial Master Files to ensure completeness, accuracy, and regulatory compliance.
Ad-Hoc Clinical Quality Consulting
Tailored support to address specific clinical quality challenges and operational needs.
Comprehensive Clinical Auditing Services
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.
Our Clinical Auditing Solutions
- Compliance Audits – Conducting audits across GCP, GCLP, GLP, non-GCP, PV, and REMS to ensure adherence to clinical and laboratory standards.
- Gap Assessments & Mock Inspections – Identifying potential compliance risks and preparing teams for regulatory scrutiny.
- For-Cause & Due Diligence Audits – Investigating compliance concerns and evaluating potential risks before regulatory action.
- Vendor & Site Qualification Audits – Assessing CROs, investigators, and sites to ensure they meet regulatory and operational requirements.
Clinical Inspection Readiness
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.
Our Inspection Readiness Solutions
- Clinical Study Gap Assessment – Identifying and addressing compliance gaps in clinical trials to mitigate regulatory risks.
- Remediation & Documentation Support – Expert guidance on remediation strategies, including storyboarding, EDC, DMF, SOP development, and CAPA implementation.
- Inspection Readiness Training – Customized training on regulatory expectations, sponsor responsibilities, and ICH E6 compliance to ensure teams are well-prepared.
- Mock Regulatory Inspections – Conducting simulated health authority inspections to evaluate and enhance clinical trial readiness.
Our Clinical QMS Consulting Services Include
QMS Assessment & Right-Sizing
Evaluating your current QMS and scaling solutions to fit your organization’s size, scope, and regulatory requirements.
Policy & Procedure Development
Creating and refining policies, SOPs, and quality documents to ensure compliance with industry standards.
End-to-End QMS Implementation
Supporting the seamless integration of quality management systems across your operations.
QMS Training & Compliance Readiness
Providing in-depth training on QMS best practices, regulatory expectations, and continuous improvement strategies.
Optimize Your QMS with Expert Support
Whether you're building a new QMS or enhancing an existing system, our experts provide tailored solutions to ensure compliance and efficiency.
Medical Device Clinical Quality Support
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.
Regulatory & Quality Support for Medical Devices
Our team specializes in supporting the unique requirements of medical device companies in meeting international compliance standards, including:
- Design Control Requirements – Ensuring clinical trial and study activities align with international regulations for product design and development.
- Clinical Trial File Management – Expert guidance in maintaining regulatory-compliant trial master files.
News & Insights
Thought Leadership Webinars Press Awards Resource Library
January 26, 2026
Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outs...
Discover how pharmaceutical and biotech companies can elevate laboratory compliance in 2026 through GLP, strategic outsourcing, and robust quality assurance.
January 14, 2026
2025 Year in Review: Regulatory Shake-Ups Reshaping Pharma Promotion in 2026
Explore 2025's FDA enforcement trends, OPDP changes, and evolving guidance shaping pharma advertising, MLR review, and compliance strategies for 2026.
News & Insights
January 27, 2026
ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero T...
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 Operations with New Office in Hyderabad
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 Welcomes Dan Ryan as President of Clinical Research Solutions
ProPharma taps Daniel Ryan as President of Clinical Research Solutions, strengthening its clinical trial management leadership and expanding its FSP Solutions.
