QMS & Regulatory Services for Start-up to DEL Approval. ERP Configuration with Cloud Hosting

Client Type: GxP System, Software & Computer System Validation, Regulatory Submissions

Jurisdiction(s):  Canada

Services Provided: Identified facility requirements, developed GMP processes for Health Canada inspection readiness. Conducted a technical review of products and coordinated validation of facility equipment for storage and shipment of pharmaceuticals. Configured ERP software with bar coding & CSV and completed regulatory affairs licensing & maintenance.