Don Carter

Welcome to Amicus, a premier GMP consulting firm, distinguished by a deep-seated culture of excellence, client dedication, and innovative thinking. We provide world-class consulting services to the pharmaceutical, biotechnology, and medical device industries, helping companies navigate the complexities of GMP regulations to maintain compliance and optimize manufacturing efficiency. Established in 2017, Amicus has assembled a team of seasoned industry veterans with decades of experience across diverse disciplines. Our vast pool of knowledge and expertise enables us to offer holistic, customized solutions that align with our clients' unique business objectives. We focus on fostering sustainable growth and competitive edge for our clients by ensuring quality, safety, and efficacy in their manufacturing processes. Our primary mission is to empower your organization with strategic insights, operational knowledge, and quality systems needed to excel in today's evolving pharmaceutical landscape. We don't just offer solutions; we build partnerships that are rooted in transparency, integrity, and mutual growth. Our comprehensive GMP consulting services encompass: Compliance Audits: Rigorous evaluations to ensure GMP adherence and establish inspection readiness. GMP Training: Personalized training on GMP principles and standards. Quality Systems: Design and implementation of robust QMS. Equipment & Process Validation: Assistance in establishing repeatable, quality processes. Risk Management: Mitigating potential risks to product quality and safety. Regulatory Consultancy: Guidance for handling regulatory affairs and compliance. Cleanroom Design: Solutions for cleanroom validation and environmental monitoring. Documentation: Support in preparing GMP-compliant technical documents. With Amicus, you gain a partner committed to your success, equipping you with the tools to navigate the dynamic pharmaceutical industry and enhance your business performance.