The Industry Leader in Compliance Services & Quality Assurance
provides comprehensive, hands-on, compliance services to the
pharmaceutical, medical device, biotechnology and dietary supplement
We will lead the way for you.
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
We help you succeed in both dimensions.
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 /
I3infotek offers the following value-added QA and compliance services:
- 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.
- 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
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