Quality & Compliance

Accelerating Success through Strategic Quality & Compliance 

Embedding Quality, Ensuring Compliance

In the highly regulated life science industry, quality and compliance are non-negotiable. Our Quality & Compliance team knows that a strategically designed and effectively implemented quality management system (QMS) is the foundation of superior performance and regulatory compliance. By providing end-to-end quality solutions, from QMS design and implementation to audit readiness and continuous improvement, we help you embed a culture of quality throughout your organization. 

Our approach focuses on driving superior performance, ensuring your products and processes meet the highest standards of quality and compliance, and building trust with regulators, partners, and patients. 

Strategic Quality Management

Effective quality management is not just about ticking boxes – it's about designing a QMS that is strategically aligned with your business objectives and risk profile. Our team of quality experts works closely with you to develop a customized QMS tailored to your unique products, processes, and organizational structure.  

By leveraging our deep regulatory expertise, industry best practices, and proven quality methodologies, we help you design and implement a QMS that ensures compliance, drives efficiency, reduces costs, and enhances product quality. 

Audit Readiness

Regulatory audits and inspections are a regular occurrence in the life sciences industry. Our Quality & Compliance team has a history of successfully helping clients achieve and maintain audit readiness, whether for routine GxP inspections or in response to specific compliance concerns.  

We collaborate with your team to assess your current quality systems, identify gaps and vulnerabilities, and develop a comprehensive audit readiness plan that ensures your processes, documentation, and personnel are prepared for regulatory scrutiny at all times. 

Continuous Improvement

Continuous improvement is crucial to maintain compliance and competitiveness in the ever-evolving life sciences industry. Our team is committed to helping you embed a culture of continuous improvement throughout your quality operations.

We work closely with your team to identify opportunities for process optimization, implement data-driven decision-making, and foster a mindset of proactive problem-solving. 

Flexible, Scalable Compliance Support

As your business evolves, so do your quality and compliance needs. Our flexible, scalable support model allows us to adapt to your changing requirements, providing the expertise and resources you need at each stage of your growth journey.

Whether you require end-to-end QMS support, targeted assistance with specific compliance challenges, or strategic guidance for quality system optimization, our team is here to provide the skills and experience you need to maintain an effective, compliant quality operation. 

Why Partner with Us?

When you choose SSI Strategy as your Quality & Compliance partner, you gain a trusted ally with a proven track record of delivering strategic insights and superior performance in quality management.  

Our unique combination of deep regulatory expertise, industry best practices, and flexible engagement model sets us apart and enables us to provide personalized solutions that address your specific challenges and goals. 

We are dedicated to thinking strategically, anticipating compliance risks, and designing innovative solutions that drive superior performance, ensure regulatory compliance, and enhance trust in your products and brand, helping you navigate the complex journey from product development to successful market entry. 


Helen Kargaryani

VP Global Head of Quality Assurance

Jacqui Levine

SVP Business Consulting


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