Our Quality Compliance Services are robust and sustainable quality systems that are the key to producing safe, consistently reliable, high-quality products and services. Unfortunately, not addressing inspection findings of regulatory authorities both in the United States and around the world can leave your company exposed to production halts, recalls, import bans, detention or production seizure— which can severely damage your organization’s product pipeline, financial health, and on-going reputation.
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- Pharmaceutical Development
- Biologics R&D
- Laboratory Testing
- Quality Compliance Consulting
- Validation Studies
- FDA Pre-Approval Readiness
- Regulatory Filing Services
- Six Sigma Projects
- FDA Inspection Remediation
- Supplier Audits
- Post market surveillance & MDR
- Quality system gap assessment
- Medical Devices Quality System
- cGMP Auditing & Training
- Quality System Development
- Equipment Qualification (IQ/OQ/PQ)
- CAPA Investigations