GALANTE COMPLIANCE SERVICES, LLC is a privately owned limited liability company that provides regulatory compliance and quality consulting services for regulated industries such as pharmaceuticals, healthcare, aerospace, and finance. GCS designs, creates, and implements practical solutions that are sustainable over time to assure quality, integrity and compliance to the satisfaction of global regulatory authorities.

AREAS OF EXPERTISE

·Six Sigma Process Excellence

·Metrics & Dashboard Design

·Quality Systems / GxPs

·ISO Certification

·Validation / 21 CFR Part 11

·Product Recall Management

·Business Continuity Planning

·Policy & Procedures Development

·Inspection Readiness Planning / Mock Audits

·Auditing

·Change Control

·Training

·Compliance / Risk Assessments

·Adverse Event & Product Quality Complaint Reporting

·Privacy Laws & Corporate Responsibility

·Healthcare Compliance

·Project Management