Our Services

Quality, Compliance
and Regulatory

Program Development

Quality, Compliance and Regulatory Program Development

We have met the challenges in developing, implementing, and sustaining efficient, effective, and compliant quality management systems, policies and procedures, SOPs for both ISO certification and worldwide GMP compliance. We have also vast experience in data integrity, quality audits, CMO management, compliance remediation, quality risk assessments and NC/CAPA program development.

  • Policies & Procedures
  • Quality Management Systems (QMS)
  • QMS: Document Management System
  • QMS: Equipment and Asset Management System
  • QMS: Maintenance Management system
  • QMS: Change Management
  • Supplier Quality Management Program Implementation
  • Data Integrity Program Development (Part 11 compliance)
  • Auditing (CMOs, Computer, IT)
  • CMO Vendor Management
  • NC & CAPA Program Development

Our Services

We offer a range of quality, compliance and regulatory services:

  • Quality Assurance Lead Backfill
  • Vendor Auditing (CMOs, Equipment Supplier Computer, IT)
  • Compliance Remediation
  • CMO Management, Quality Agreements, Person In Plant
  • CMO Capacity and Feasibility Analysis
  • Quality Risk Assessment
  • NC & CAPA Ownership
  • Investigation & Root Cause Analysis Program Implementation
  • Regulatory Strategy & Submissions
  • Regulatory Inspection Preparation & Readiness
  • Audit Preparation & Support


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