Who We Are

LSPediA is a management consulting company and a system integrator specializing in the Pharmaceutical and Medical Device industries. We help clients meet stringent regulatory requirements and their growth target by building out the right technology infrastructure tailored to their size, specialty, and core business. LSPediA has the capability to provide strategy planning, vendor selection, implementation, and validation services in the areas of DQSA, Serialization, Track-n-Trace, UDI, and GMP Compliance leveraging our expertise in Serialization, ERP, PLM, QMS, MES, EPCIS, and and LMIS.  LSPediA Company Profile

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