Specialists in Quality Management and Regulatory Compliance
WHO WE ARE
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 diversified product portfolios.
OUR COMPANY AT A GLANCE
LENAPE ADVANTAGE
Quality System Design
We cover the full spectrum of experience in setting up and managing Quality Systems to support Pharmaceutical Development and Commercial Manufacturing.
WORRIED ABOUT AN FDA OR EMA cGMP COMPLIANCE MATTER?
Lenape can perform a Gap Analysis at your site(s) to help prepare for an inspection. If you have had a difficult inspection result, we can help you define an appropriate Corrective Action Plan to resolve the issues identified.
We work diligently to make sure our communications from the beginning to the end of each project allow us to understand your situation and needs in the proper regulatory context. Every assignment considers the impact of all applicable regulations and applies a life cycle approach to determine a customized solution. It is our desire to earn your trust and become your first choice when looking for cGMP regulatory compliance or quality system support.