Kristopher Le's Contact Details

Kristopher Le's Company Details

amicus GMP Consultants

Lexington, South Carolina, United States • 6 Employees
Pharmaceuticals

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