Services Offered

Enterprise Applications

  • DQSA Solutions
  • Enterprise Resource Planning (ERP)
  • Supply Chain Management
  • Warehouse Management
  • Product Life Cycle Management (PLM)
  • Quality Management Systems (QMS)
  • Manufacturing Execution Systems (MES)
  • EPCIS
  • Laboratory Information Management System (LIMS)

DQSA / SERIALIZATION

  • Strategy planning
  • Gap Analysis
  • Process design
  • Request For Proposal (RFP)
  • Vendor Selection
  • Implementation
  • EDI
  • Validation
  • Project Management
  • CMO management

MEDICAL DEVICE FDA COMPLIANCE 

  • Unique Device Identification (UDI)
  • UDI submissions
  • Medical Device Data Systems (MDDS)
  • Audits and CAPA
  • Risk assessment
  • Clinical trials
  • FDA 483s
  • 510(k), PMAA, pre-IDE, de novo, CE Mark
  • Facility registrations and device listings
  • Annual reports
  • Supplier audits
  • Healthcare IT

PHARMACEUTICAL FDA COMPLIANCE

  • Registrations CMC, NDA, ANDA, DMF
  • Pre-approval inspection
  • FDA audit
  • FDA 483s
  • Clinical and scientific program management
  • Process automation and analytical technology
  • Laboratory, process, and analytical development
  • Technology transfer
  • Licensing-in and licensing-out
  • Foreign establishment U.S. Agent
  • Project management