Strategic Advisory & Regulatory Affairs
Expert counsel to navigate complex regulatory landscapes, optimize quality management systems, and ensure sustainable, enterprise-wide compliance.
Our Advisory Philosophy
We employ a proactive, risk-based methodology that transforms compliance from a regulatory burden into a strategic advantage. Our objective is to move beyond mere adherence, architecting quality systems that drive efficiency, innovation, and market confidence. We partner with clients to build scalable, future-ready frameworks that enable and sustain growth.
Core Advisory Areas
QMS Architecture & Implementation
Design, remediation, and implementation of robust Quality Management Systems compliant with ISO 13485, ICH Q10, and global GxP standards.
Data Integrity & Governance
Establishment of comprehensive data integrity programs founded on ALCOA+ principles to ensure data is accurate, complete, and secure across its lifecycle.
Regulatory Affairs & Submissions
Strategic guidance on regulatory pathways and preparation of high-stakes submissions for health authorities including the FDA, EMA, and SFDA.
AI in GxP Environments
Navigating the regulatory complexities of implementing AI and machine learning in regulated processes, ensuring compliance and validation.
Pharmacovigilance & Clinical Quality
Strategic support for drug safety operations and quality assurance for clinical trials to maintain GCP and GVP compliance.
Quality Risk Management (ICH Q9)
Implementation of ICH Q9-based risk management programs to proactively identify, analyze, and mitigate quality and compliance risks.
Ready to Enhance Your Compliance Framework?
Let's build a resilient, efficient, and inspection-ready future for your organization. Schedule a complimentary, no-obligation consultation with our experts to discuss your specific challenges and discover how Akatalyst can be your catalyst for success.
Our Product Suite
Our pre-validated, GxP-compliant software simplifies quality management, with an optional AI layer to unlock next-gen efficiency.
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