Lenape Pharma GMP Consulting, LLC

Lenape Pharma GMP Consulting, LLC is a United States based startup founded in 2016 that specializes in providing expert, hands-on support for Quality Management Systems and cGMP Regulatory Compliance for Pharmaceutical and Biopharmaceutical companies. Their services range from assisting startups in developing their first drug product to aiding large companies with global reach and diverse product portfolios. Lenape's offerings include consultation, risk assessment, and remediation of FDA, EMA, and other regulatory agency compliance actions, quality management system design and implementation, supplier selection, evaluation, approval, and oversight, evaluation of cGMP aspects of new facility design and start-up, and in-depth inspection of facilities, systems, and documentation to ensure readiness for critical inspections. Additionally, the company provides man-in-plant support during critical technology transfer and manufacturing operations. Lenape Pharma aims to address the crucial regulatory and quality management needs of pharmaceutical and biopharmaceutical companies, making it a promising investment opportunity for venture capitalists seeking exposure to the manufacturing and pharmaceutical sectors.