Our Offerings
Launch Excellence
Ensuring a Seamless Transition from Approval to Market Success.
At AZB Consulting, we provide comprehensive support to companies during the critical phase of product launch.
Our services are designed to ensure compliance, operational readiness, and strategic alignment, facilitating a successful market entry.
Our comprehensive approach addresses the multifaceted challenges of launching a new medical device, providing strategic and operational support tailored to each client’s needs.
Our Expertise
Our Launch Excellence Services Include:
Launch Readiness & Strategy
We design tailored launch readiness plans that integrate regulatory preparedness, supply chain coordination, and cross-functional stakeholder engagement. This ensures a smooth and timely product launch across target markets.
Promotional Material Review & Sign-Off
We offer regulatory advice on local requirements, regulatory and review for the validation of promotional materials. We support you to develop your global and local compliance SOPs and training materials.
Our team ensures that all promotional content complies with applicable laws at EU or local level. We support you in all EU countries as required.
Quality System and Audit
We support the establishment and auditing of quality management systems to ensure compliance with ISO 13485:2016 and other specific standards requirements.
Our team prepares companies for audits and implements corrective and preventive action plans (CAPAs) when needed.We can provide you with the local responsible person as required (PRRC) by the MDR 2017/745.