Pharmaceutical Business References

Research

  • Bioinformatics: Genomic Sample Annotation, Proteomic LIMS — Chemical & Biological Data Warehouse — GLP validated Substance Management System — Compound Management: Sample Administration Systems, Automated Sample Factories — Scientific Reporting

LIMS / Pre-clinical

  • GLP validated Bioanalytical LIMS — GLP validated LIMS for AMES testing — GMP validated LIMS for Galenic Development — GLP validated Pharmacokinetic / Toxicokinetic LIMS — Toxicological Study Management

Clinical Development

  • Clinical Data Process Facilitation — Clinical Remote Data Entry — Clinical Trials Management System — Departmental Intranet Portals — Disease Specific Portals — Intranet Portal Factory — Life Cycle Portals — Oracle clinical

Regulatory Affairs

  • Electronic Archiving — Document Management — Electronic Data Capture, Transfer and Submission — Pharmacovigilance

Pharmaceutical Production

  • GMP validated Manufacturing Execution System including Electronic Batch Recording — Manufacturing Data Collection for Process Optimization

Quality Assurance & Validation

  • GCP Qualification of a Management System for Clinical Audits — GMP Validation of a Monitoring System for Tabletting Machines — LIMS for Pre-clinical Development — LIMS for Mutagenicity Testing — Part 11 Gap Analyses — Retrospective GLP Validation of a Toxicological LIMS — Retrospective GCP Validation of Planning & Administration of Clinical Studies — Retrospective Validation of a multilingual Clinical Product Labelling System

Infrastructure

  • Automatic System Upgrade — Infrastructure Qualification — System Migration — Ticketing System Customizations

Pharmaceutical Business

  • Budgeting and Forecasting — Business Performance and Strategic Planning — Competitive Intelligence — Corporate Communication Portals