Lenape Pharma GMP Consulting, LLC
Pharmaceuticals - Raleigh, North Carolina, United States
Lenape Pharma GMP Consulting, LLC Employees
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Lenape Pharma GMP Consulting, LLC Details
Lenape Pharma GMP Consulting, LLC provides expert, hands-on support on matters pertaining to Quality Management Systems and cGMP Regulatory Compliance for Pharmaceutical and Biopharmaceutical companies ranging from start-ups developing their first drug product to large companies with global reach and diverse product portfolios. Lenape services include, but are not limited to:• 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• In-depth inspection of facilities, systems and documentation to ensure readiness for critical inspections by FDA, EMA, Japanese PMDA and other regulatory agencies• Man-in-Plant support during critical technology transfer and manufacturing operations
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