Who We Are

As a leading life sciences management consulting company, LSPediA specializes in complex operational, compliance, and technology project deployment. LSPediA has the capability to provide strategy planning, vendor selection, implementation, and project management services in the areas of Serialization, UDI, FDA compliance, Validation, ERP, PLM, QMS, MES, EPCIS, Data Analytics, and LMIS.  LSPediA Company Profile

Services Offered

ERP, PLM, QMS, MES, EPCIS, LIMS

  • Strategy planning
  • RFQ
  • Vendor Selection
  • Supplier Audit
  • Implementation
  • Validation
  • Project Management
  • Data analytics

H.R. 3204 SERIALIZATION

  • Strategy planning
  • Gap Analysis
  • Process design
  • RFQ
  • 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