Mario Ami

At GMP Healthcare, we specialize in providing innovative and comprehensive healthcare solutions tailored to meet the unique needs of our clients. Our team is dedicated to advancing health outcomes through high-quality products and exceptional service in various sectors, including pharmaceuticals and medical devices. We believe in fostering strong partnerships with our stakeholders to drive positive change in the healthcare landscape. Join us in our mission to enhance well-being and empower communities through effective healthcare solutions. Numerous companies face challenges in maintaining the quality of their products and services, given the intricate landscape of legislation, standards, and certifications. We provide comprehensive Quality Assurance (QA) services essential for safely and compliantly bringing your product to market. This encompasses conducting in-depth cGxP audits conducted by certified auditors, the establishment of a Quality Management System (QMS), and all activities related to the final release of the product. QUALITY IMPLEMENTATION SERVICES A streamlined Quality Management System (QMS) should be in harmony with your business needs and objectives. Our subject matter of experts possess the expertise, capabilities, and approach required to assist a company in developing and outlining a top-tier quality system. We provide ongoing QMS management support as required by our clients at their facilities. We have reviewed and improved our client’s entire Quality Management Systems in line with cGxP principles. We have also developed complete lean and phase-appropriate Quality Management Systems for pre-clinical and start-up clients. We offer simulated inspections for Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). We provide coaching for individuals and teams involved in regulatory inspections, covering best practices for running the documentation room and managing the inspection process.