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. Currently Working with: • Large Hospital System 503B Facility Development & Project Management • Pharmaceutical Manufacturers Regulatory Licensing & Permitting Equipment Commissioning & Validation Temperature Mapping • Multiple 503B Facilities Facility Design & Project Management Process Validation Services • GAP Analysis (503B Outsourcing Facilities, USP <797>, & USP <800>) • Process Optimization and Validation • Quality Systems Development • Quality Assurance Staff Augmentation • Equipment Commissioning and Qualification • Sterilization Validation (Dry-Heat and Moist Heat) • Temperature Mapping (Warehouse, Refrigeration, Incubators, etc.) • Due Diligence Audits • Consent Decree Remediation • Expert Witness Services