SERVICES

Quality and Compliance

Specializing in deviation/investigation, CAPA and Change Controls,  we develop solutions that address your quality and regulatory compliance processes. Protect your business and increase your efficiency by leveraging our strategy to manage systems implementations, process improvement, audits, and remediation of problems. We work closely with your quality team to evaluate procedures, conduct compliance audits, develop risk mitigation, and action plans, create efficient documentation and reporting systems, and assist with regulatory filings — all the critical activities that lead to reproducible and reliable quality production.

Services We Offer

Compliance Audits

Development and Management of Compliance Action Plans

Regulatory Readiness Inspections and Training

Response to Regulatory Citations and Warning Letters

Design of Quality Systems for New Facilities or New Processes

Ongoing QA/QC Support

QMS Implementation

Preparation of Regulatory Filing and Review Documents

Implementation of Quality by Design (QbD) Approaches

CAPA Management

Quality Risk Management

Quality Systems Audits

Deviation and Investigation

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