Quality & Regulatory Compliance

Ensuring you meet oversight requirements

Our consultants have practical experience and proficiency with respect to a wide range of Quality, Compliance, and  Regulatory topics. We assist our clients in developing a solid strategy for their manufacturing, quality, and regulatory activities by utilizing our successful hands-on experience to support them with shop floor GMP manufacturing challenges in Research, Commercial, and Clinical products across a multitude of formulation platforms. We specialize in providing support in Quality Management Systems, Quality (CAPAs, Investigations, BR’s Management Review, Process/Analytical Validation, SOPs), Compliance Needs (Storyboards, Warning Letter Response/ Remediation), cGMP auditing including internal and external (CDMO/CMO, API and suppliers) plus audited firm follow-up, QC Laboratory (Data Integrity, OOS Investigations, SOPs) and Inspection Readiness (Inspection Preparation, Mock Inspections, Training, Back Office Support, Response Letters, CAPAs, and Storyboards) and much more.