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