QUALITY ASSURANCE
We provide quality as a fundamental principle in all area of research. Our QA team delivers strategic strength to our operation to ensure any day of compliance. QA group strives to keep Oneiric Internationals head high in the industry via quality by design concept as an enabler. Our systems are flexible enough to foster steady improvement and are firm enough to ensure quality and compliance.
Quality Assurance Services
- Client Audits
- SDEA/ Partner Audits
- QMS Setup
- Vendor Qualification
- Alliance Partners Due Diligence
- Computer System Validation
- Pre-Audit/Inspection Readiness
- Change Management
- Deviation Management
- Gap Analysis
- Investigator Site Audits
- Regulatory Document Audits ( IBs, regulatory submission documents, PSMF etc.)
- GxP Trainings
Project Specific Quality Compliance Assessments
- Pharmacovigilance Audits
- Alliance Partner/ Business Partner Audits
- Project specific consultancy service tailored to the client’s requirement
- Review of Essential Documents
- Vendor Due Diligence
- TMF Assessments
- Clinical Trial Site Assessments
GxP/Compliance Audits
- Investigator Site Audit
- Client Audit
- Alliance Partner/ Business Partner Audit
- PSMF Gap Assessment
- QMS/ Process System Compliance Audits
- Pharmacovigilance Audit
- Vendor Audit
- Trial Master File Audit
- Database and Document Audit
- Effectiveness Audits of QMS
- Corrective Actions & Preventive Actions (CAPA)
