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Coastline

The Power 
of Great Consulting.

Empowering companies to elevate their Quality Compliance standards and drive success with

confidence.

Services

SERVICES

Let's elevate your Quality Systems to new heights and unlock its full potential.

Quality Systems Design, Strategy & Implementation

  • Quality Systems Development

  • Data Integrity

  • Quality IT Systems

  • Quality Remediation

  • Management Controls

  • Risk Management

  • Train and Qualify Staff

  • New/Revised Standard Operating Procedures

Lab Controls & Data Integrity

  • Quality Control Operations Assessment

  • Data Integrity Remediation

  • Quality Control Organizational Assessment

Quality Operations Support

  • Management Review

  • Validation & Qualification

  • Risk Management

  • Laboratory Controls

  • Batch Review

  • Quality Engineering

  • Deviations

  • Post Market Surveillance

Quality Systems Auditing & Assessment

  • Due Diligence

  • Internal Audits

  • Effectiveness Assessments

  • Supplier Assessments

Remediation Strategy & Support

  • Oversight services 

  • Regulatory response (483 and Warning letter)

  • 21 CFR Part 210 and 211

  • 21 CFR Part 11 

  • 820

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