Services

AVIC Solutions offers tailored development, implementation, and continuous improvement of Quality Management Systems aligned with ISO 9001, GCP, GMP, and global standards.

• Design and build custom QMS frameworks
• Conduct QMS implementation and optimization
• Perform independent QMS audits and compliance assessments
• Support organizational structure planning
• Provide strategic quality planning and consultancy

We deliver hands-on quality oversight to help organizations control operational risk, manage compliance across workflows, and ensure product and process integrity.

• Establish and manage document control systems
• Create and maintain training and competency programs
• Implement and monitor quality metrics (KPIs)
• Manage risk mitigation frameworks
• Handle deviation, CAPA, and change control processes
• Review batch records and release CoAs
• Oversee clinical trial quality systems and SOP compliance

From mock inspections to full audit programs, our Certified Quality Auditors offer end-to-end services to ensure you meet regulatory expectations and maintain inspection readiness.

• Develop audit strategies and annual audit plans
• Conduct internal, supplier, and vendor audits
• Host regulatory inspections and client audits
• Prepare organizations for FDA, EMA, MHRA, and Health Canada inspections
• Identify and resolve audit findings with post-inspection CAPA support

We support SaaS providers, life science platforms, and trial technology with full Computer System Validation (CSV) and quality system integration.

• Perform GxP-compliant CSV and lifecycle documentation
• Validate EDC, CTMS, eTMF, and clinical systems
• Build AI-assisted compliance tracking systems
• Draft and revise SOPs, policies, and technical documentation
• Support technology transfer and system implementation planning

Led by a CIPP/E, we provide data privacy services aligned with GDPR, HIPAA, PIPEDA, DPF and global frameworks — without the burden of in-house staffing.

• Serve as a Fractional Data Protection Officer (DPO)
• Draft, review, and negotiate Data Processing Agreements and SCCs
• Conduct DPIAs, PIAs, and TRA assessments
• Design breach response and notification procedures
• Develop privacy notices and data subject response frameworks
• Maintain Records of Processing Activities (ROPA) and data maps
• Conduct global privacy compliance gap assessments
• Provide ongoing privacy consultancy and compliance tracking
• Assist in the certification of Data Privacy Frameworks (DPF)

We help build, secure, and scale ISMS programs in line with ISO 27001 and NIST cybersecurity frameworks.

• Lead ISO 27001 readiness and certification support
• Conduct cybersecurity and infrastructure risk assessments
• Evaluate third-party vendors and manage supplier risk
• Create incident response, disaster recovery, and business continuity plans
• Advise on access controls and data governance models
• Secure cloud platforms (AWS, Azure) and validate SaaS environments
• Deliver security awareness training and build security policies

We offer additional consulting and project-based support across regulated operations.

• Clinical QA leadership and inspection readiness programs
• Strategic regulatory compliance planning
• Design and alignment of regulatory roadmaps
• Custom training development and facilitation
• Support for system implementations and upgrades
• Governance for AI, digital health, and emerging technologies

Led by experienced governance and regulatory professionals, we provide AI governance services aligned with emerging global AI regulations and industry frameworks, supporting the responsible, transparent, and risk-based use of Artificial Intelligence across regulated and enterprise environments.

• Serve as a fractional AI Governance Lead or Advisor
• Develop AI governance frameworks, policies, and procedures
• Support alignment with the EU AI Act and global AI regulatory expectations
• Perform AI risk classification and impact assessments
• Establish human oversight, accountability, and escalation models
• Define AI lifecycle governance, including development, deployment, and monitoring
• Integrate AI governance into existing quality, privacy, and information security frameworks
• Support vendor and third-party AI risk oversight
• Provide ongoing AI governance advisory and compliance tracking