Our services for GxP market research
Market definition instead of gut feel
Before a system or device is purchased, the market must be clear: scope, inclusions and exclusions, relevant vendors, budget. We gather primary data, maintain comparison databases and keep analysis tools current.
The next step is often supplier qualification. The full lifecycle is on the GxP network map.
Services
Market definition and exploration
We set the relevant target market and document scope. Primary data, databases and analysis tools stay usable for the sourcing team.
Competitor analysis
We identify and assess the three to five most relevant competitors, including budget. Competitor matrices show positioning, strengths and weaknesses.
Regulatory framework
GxP procurement is governed by Chapter 5 of the EU GMP Guide (EudraLex Vol. 4): suppliers of critical materials and services must be assessed before award, and the assessment must be documented. Market research provides the data for that assessment, and GAMP 5 requires the same rationale for software suppliers.
Selection process and evidence
We coordinate first and final meetings plus vendor presentations, support pilots and feasibility studies, and document the full selection process for internal audits, external inspections and compliance evidence. Delivery sits in project management.
Umfang klären?
Erstgespräch vereinbarenLeistungs-Wegweiser
Welche Ausgangslage beschreibt Ihr Vorhaben?
Wählen Sie die Ausgangslage. Sie erhalten einen fokussierten Startpunkt mit Vertiefungen und Kontaktweg.
Vom Erstgespräch zum Plan
Wir klären Umfang, Rollen, Risiken und regulatorischen Rahmen und schlagen einen belastbaren Fahrplan vor.
Finding schließen
Root Cause, CAPA und Nachweise strukturiert aufbauen und QA-Abschluss vorbereiten.
Programm statt Einzelprojekt
PMO, Change Control und einheitliche Vorlagen über viele parallele Vorhaben hinweg.
Before a system or device is purchased, the market must be clear: scope, inclusions and exclusions, relevant vendors, budget. We gather primary data, maintain comparison databases and keep analysis tools current.
Our approach in GxP projects: from planning through release – each step delivers evidence you can present in QA review and audit. View GxP consulting in five steps
FAQ: Market research
Reference projects in practice
LIMS, DI gap assessment, and supplier qualification as proven examples.
Project management
LabWare LIMS rollout
LabWare V8.0 for around 400 users plus a global SAP update: PMO, requirements, and change management.
View case story
Reference
DI gap assessment
System landscape plus gap assessment on validated GxP software until findings are closed.
View case story
Reference
FDA-ready supplier qualification
Gap analysis and supplier qualification through to a passed FDA inspection.
View case story