Compliance & Quality Assurance

Compliance & Quality Assurance

The Industry Leader in Compliance Services & Quality Assurance

I3infotek provides comprehensive, hands-on, compliance services to the pharmaceutical, medical device, biotechnology and dietary supplement industries.

We will lead the way for you.
I3infotek clients expect more than just a partner that provides hands-on support. As our client, you can expect that not only will we work alongside you providing quality compliance services, but we will provide the strategy and training to help you improve quality systems and mitigate future risk.

We help you succeed in both dimensions.
I3infotek will work with you to set the direction, lay out the plan, and execute the plan - saving you time and money, as you optimize your Quality / Compliance programs.
I3infotek offers the following value-added QA and compliance services:

Quality Assurance:
  • QA/Quality Control Resource Management
  • Policy, SOP & Batch Record Review, Preparation & Optimization
  • Quality System (QS) Development, Assessment & Optimization
  • Root Cause Investigations & Corrective & Preventive Action (CAPA) Planning & Execution
  • Training – FDA, GMP, QSR, DQSA, USP <795>, USP <797>, Validation, etc.

Compliance Services:
  • Third-party GMP & GLP Compliance Auditing
  • Mock FDA/International Regulatory Agency Inspections & PAI Readiness
  • Due Diligence Compliance Inspections, Audits & Assistance
  • FDA Action (483 Observations, Warning Letters, Consent Decrees) Remediation

As a compliance company, our experinced quality, compliance and program/project management professionals take a proven, hands-on approach to addressing our clients’ specific QA and compliance situations to ensure their quality and regulatory operations are in compliance with current industry standards and FDA/international regulations.