Auria Consulting Group delivers targeted, high-impact GMP & Regulatory Compliance consulting to pharmaceutical, API, dietary supplement, and broader life sciences companies seeking to transform quality systems, ensure regulatory compliance, and achieve sustainable operational excellence. Leveraging deep expertise across global GMP regulations, we proactively help clients navigate complex and emerging regulatory landscapes, align quality objectives with business priorities, and establish resilient, future-ready compliance frameworks.

Our collaborative, hands-on approach combines advanced regulatory intelligence, practical quality culture strategies, and innovative technology solutions. We work closely with clients to assess and optimize systems, address compliance gaps comprehensively, and co-develop scalable, regulator-aligned programs designed to maintain continuous compliance and operational agility.

Our comprehensive GMP & Regulatory consulting services include (but not limited to):

• Advanced regulatory strategy development, including specialty guidance for emerging product categories (e.g., biologics, complex APIs, complex dietary supplements)

• GMP gap analysis with detailed compliance roadmaps tailored to evolving global standards

• Comprehensive regulatory inspection readiness programs, incorporating advanced analytics and virtual audit capabilities

• End-to-end Quality Management System (QMS) design, implementation, and optimization tailored to multi-site integration

• Quality culture assessment and structured transformation initiatives aimed at embedding GMP compliance into organizational DNA

• Risk-based remediation planning and hands-on execution supported by predictive analytics

• Strategic regulatory affairs support throughout the product lifecycle, from development and filings through post-approval maintenance

• Comprehensive technical validation services, including continuous validation strategies for advanced manufacturing environments (AI/ML systems, automation, digital technologies)

• Vendor qualification programs enhanced by rigorous audits, remote inspection capabilities, and secure digital oversight

• Seamless integration of advanced digital compliance tools (e.g., AI-driven systems, cloud-based QMS platforms) ensuring robust data integrity and security

• Specialized due diligence support for mergers, acquisitions, and strategic partnerships, emphasizing rapid compliance assessment and integration planning

Let’s work together to build you a more resilient, compliant, and forward-looking quality culture.