Kristopher

Experience

1. CEO & Managing Partner

   amicus GMP Consultants

   Mar 2019 — Present

   AMICUS is a consulting company providing efficient solutions to meet today\'s regulatory issues. We are a hands-on firm that believes in providing results beyond just “reports only.” At AMICUS, we provide a large range of services to FDA regulated compounders and manufacturers, all designed to meet our client’s specific needs. Our areas of expertise include: GMP Compliance: We provide comprehensive compliance assessments, audit preparation, and remediation services to ensure that our clients\' facilities, processes, and systems meet or exceed the FDA\'s current Good Manufacturing Practice (cGMP) regulations. Quality Systems: Our team helps clients develop and implement robust quality management systems that ensure consistent product quality and compliance with FDA regulations. We provide guidance on all aspects of quality, including document control, change control, deviation management, and CAPA (Corrective and Preventive Action) systems. Validation: We offer validation services that ensure that our clients\' equipment, facilities, and processes are qualified to operate within specified parameters and meet regulatory requirements. Our services include equipment qualification, process validation, cleaning validation, and computer system validation. Training: We provide comprehensive training programs to help our clients develop a culture of compliance and ensure that their employees have the knowledge and skills necessary to meet regulatory requirements. Regulatory Affairs: Our team of regulatory experts provides guidance on all aspects of FDA regulatory compliance, including product submissions, labeling, advertising, and post-marketing surveillance.