Quality Assurance
ClinMax for Study Rescue:
Quality Assurance:
Internal system audits
Quality assurance pharmaceutical practices involve thorough internal system audits to verify compliance and identify areas for operational improvement.
Site preparation for regulatory inspections
Control and quality assurance measures guide site preparation for inspections, promoting adherence to regulatory standards and minimizing risks.
Vendor qualification audits
Quality assurance pharma processes include vendor qualification audits to evaluate and validate suppliers, ensuring reliable and compliant partnerships.
Regulatory document audits
Detailed audits of protocols, CSRs, IBs, and submission documents uphold quality assurance pharmaceutical standards, ensuring regulatory accuracy.
Management of a Corrective and Preventive Action (CAPA) & Follow-up
Effective CAPA management within quality assurance pharma ensures prompt resolution of issues and continuous improvement in processes.
Risk Evaluation and Mitigation Strategies (REMS) consulting
Through REMS consulting, quality assurance pharma services help identify and mitigate risks, enhancing the safety of pharmaceutical products.
Developing, Reviewing & updating existing SOPs
Quality assurance pharmaceutical services focus on creating and refining SOPs to support efficient and compliant operational workflows.
Assessment or Developing audit plans
Comprehensive audit plan assessments developed by quality assurance pharma experts optimize monitoring and ensure consistent regulatory adherence.
QA full-Service Delegation/ Outsourcing
Delegating QA services to quality assurance pharmaceutical providers ensures comprehensive oversight and efficient management of quality processes.
Adverse Event / Pharmacovigilance Audits
Quality assurance pharmaceutical teams conduct adverse event audits to ensure robust pharmacovigilance and patient safety measures.
Update/Revise Existing SOPs
Regular updates to existing SOPs reflect control and quality assurance efforts, maintaining relevance and compliance with industry standards.