Bellatriks Consulting
Pharma IT, GxP and Validation Partner

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Bellatriks Consulting offers a comprehensive consulting services within Medical Device, Pharma IT, Audits, Project Management, GMP, GDP and Validation.

Medical Devices

  • Implementing Quality Management System - QMS
  • Writting Clinical Evaluation Report
  • Performing Risk Assessment - FMEA
  • Creating Device Master Records - DMR
  • Creating Classification Rationale document acc. to MDD 93/42EC
  • Creating Quality Agreement
  • Perform audits, Supplier Audits on behaft of your company
  • Writting SOP (Standard Operation Procedures
  • Writting validation Protocols/Reports of:
  • Validation of Excel Spreadsheet, Validation of Analysis Method, Validation of Laboratory Equipment

Pharma IT

We help our clients with the following offerings:

  • Consultancy on Technical solution of Pharma IT
  • Implementation of Parexel Insights and Aris Global Register
  • Writing and reviewing Technical Design Specifications
  • Code Review in Java, PL/SQL, Java Script, C#
  • Configuration Management Strategy
  • Assessment of new IT application and recommendation
  • System Interfaces