Compliance Management

Protocol Link’s Compliance Team will work with your group to evaluate an under-performing function, identify compliance gaps, and perform mock inspections and audits.

Compliance Management Services

Need Compliance Management services you can trust?

We bring forth the best demonstrated practices from the industry by providing comprehensive evaluations of your business operation. Our staff of seasoned professional auditors have experience with FDA, ICH, and international regulatory agencies and will assure global standards are appropriately addressed and achieved.

We keep up with the latest industry regulations and best practices so we can provide you with compliant solutions.

Protocol Link has experience in developing targeted processes, product profiles, equipment specifications, facility design, and quality systems which meet the various requirements of regulatory agencies inside and outside of the United States.  We design quality into your products and processes by creating policies, procedures, and practices for executing your business requirements.

Protocol Link is comprised of qualified, industry-savvy leaders in manufacturing operations, quality systems, laboratory practices, and technical processes.  With over 900 projects completed to date, representing engagements in more than 30 countries worldwide, we will effectively apply our experience and knowledge to your business success.

Our Compliance Management services include...

483 and Warning Letter Responses and Remediation

Consent Decree Responses and Remediation

Corrective and Preventive Actions (CAPAs)

Data Integrity Assessments and Remediation

FDA Inspection Readiness

FDA’s Six System Based Reviews

Gap Analyses

GMP Compliance Reviews and Assessments

ICH Reviews and Assessments

ISO 13485 Assessments

Mock FDA Inspections

Mock FDA Inspections

Quality System Action Plan Implementation

Quality System Regulations (QSR)