Bringing a new vantage point to every partnership

In today’s rapidly evolving global landscape of regulations & standards, Quality Management System (QMS) assessments are critical for organizations to ensure regulatory compliance, identify & mitigate risks and drive continuous improvement for product quality and patient safety

Product development with robust design controls and risk management are the foundation of creating and maintaining high quality products. We support the end-to-end product development lifecycle and creation of design history file (DHF), all the way from conceptualization through successful design transfer into manufacturing, complying with state-of-the-art risk management principles.

Understanding that CAPA (Corrective and Preventive actions) timeliness and Non-conformance resolution are key challenges and areas most prone to regulatory inspections, we will work with you to project manage them not only to drive timely completion of actions but also embed critical thinking into the process. This will drive timely release of products and enable robust documentation.

With an increase in outsourcing activities in the recent years and the emphasis on embedding risk-based approaches, our team will help develop well-engineered purchasing & supplier control processes to consistently meet both organizational and regulatory requirements. This includes on-boarding suppliers via diligent evaluations and audits, establishing appropriate agreements, periodic monitoring of supplier performance, resolving audit findings and supplier issues to drive business continuity.

Internal auditing is not merely a regulatory requirement, it serves as a critical too to verify that your organization is truly operating in compliance with the applicable regulations, standards and your organization’s own policies, procedures and work instructions. Whether performing internal audits, remediating audit findings, or conducting mock audits in preparation of certifications and unannounced inspections, we provide support for all activities allowing your team to stay focused on innovation and strategic growth.

Complaint handling and post-market surveillance are among the most scrutinized areas during regulatory inspections, making it essential for organizations to maintain robust, well-documented processes. We provide strategic and tactical support in strengthening these processes, helping you ensure compliance, timely reporting, identify trends, and drive continuous product and process improvement.

Inorganic growth through mergers and acquisitions has surged in recent years, particularly within the life sciences, MedTech and private equity sectors. Buyers are increasingly recognizing the critical importance of incorporating quality-focused due diligence to effectively evaluate acquisition targets. This approach enables organizations to: (i) identify potential quality or regulatory issues with authorities before deal closure, (ii) appropriately plan and allocate resources for Transition Service Agreement (TSA) activities related to Quality during early integration, and (iii) facilitate a smooth and successful post-merger integration.

Navigating through ever changing complex global regulatory requirements is cumbersome, yet vital to ensure timely product release and market access while avoiding costly delays and compliance risks. We support organizations by providing expert guidance on developing regulatory strategies and creating streamlined regulatory pathways which are important factors for commercial success. Our highly experienced team will chaperone you through the requirements and associated documentation to meet international regulations with confidence.

Organizational transformation and change begins with alignment, from leaders to shop floor associates. Ensuring that every employee understands their role in driving quality and compliance is critical to achieving meaningful, lasting change. We will coach you and your team by delivering targeted workshops and training programs that build capabilities, foster awareness, and create a unified culture focused on continuous improvement to better patient outcomes.