Quality that stands up to inspection. Senior expertise, tailored to your organisation.
Qualitice is a founder-led GxP consultancy for life sciences. We validate GxP-critical systems, prepare you for inspections and lead regulated programmes end to end.
What you can verify before you hire us
A boutique consultancy built on 15 years of senior practice in Europe and the United States.
“We stay deliberately boutique. I stay personally involved in every engagement.”
Fifteen years in life sciences across Europe and the US: in-house roles at Roche Diagnostics in Germany and Washington, DC, and senior mandates for Boehringer Ingelheim, Novartis, Lonza, Fresenius Kabi, Merck, BASF and Johnson & Johnson.
ISPE mentor
More systems, faster change, new regulations. And quality is expected to keep up.
Regulators are raising the bar. Computer Software Assurance shifts the focus from paper volume to critical thinking, and with draft Annex 22 the EU has published its first GMP guidance for artificial intelligence in manufacturing.
At the same time, your system landscape keeps growing: cloud platforms update multiple times a year, ERP migrations are due, and the first AI features are already inside vendor products. Keeping quality ahead of that pace, without adding headcount or losing rigour, is exactly what we help with.
The highest standard of work.
Tailored to every client.
Every organisation is different, culturally and technologically. We adapt how we work to your teams, your systems and your pace.
Senior consultants own it
Every engagement is led by an experienced consultant who has validated the systems they manage. Requirements, risk, testing and documentation are structured to GAMP 5 and CSA logic from day one.
Efficient, on your terms
Proven templates and methods keep the work efficient. Where you want it, AI-assisted drafting adds pace under human-in-the-loop governance.
Quality before anything
Every deliverable is challenged and approved by a senior expert against your systems, your processes and the inspection reality we know first-hand. Critical thinking is the product.
Compliance is a science. We treat it like one.
Evidence over paper volume. Critical thinking over checklists. Judgement over templates.
Where we go deep
Five areas of deep expertise, from a single workstream to full programme delivery.
Project & programme management
End-to-end leadership for regulated system implementations: ERP, LIMS, MES and document management platforms such as SAP S/4HANA or Veeva Vault. Programme and workstream leadership, PMO, data migration with integrity controls and change management: one accountable lead from kickoff to hypercare.
→ S/02CSV / CSA validation
GxP-critical systems validated rigorously and efficiently: ERP, LIMS, MES, eDMS and QMS platforms, on-premise or cloud. Risk-based to GAMP 5 (2nd Ed.) and FDA CSA logic, delivered as an inspection-ready package.
→ S/03Audit & inspection readiness
Mock inspections, data integrity gap assessments (ALCOA+), supplier and vendor audits, CAPA strategy and remediation, run by people who know what FDA and EMA inspectors actually look for.
→ S/04Data integrity
ALCOA+ gap assessments, data flow mapping, criticality assessments and audit trail review strategies: pragmatic remediation instead of shelf-ware policies.
→ S/05AI in GxP
AI features are arriving inside Veeva, SAP, LIMS, MES and QMS releases you already run. We inventory them, decide and document what is in GxP scope, qualify what stays and design the human oversight around it, working to the ISPE GAMP AI Guide, draft Annex 22 and the EU AI Act.
→DACH-grade quality. Barcelona economics.
Our delivery hub sits in Barcelona: your timezone, your language, and a meaningful rate advantage over DACH onshore resourcing.
Your timezone
Barcelona works when Frankfurt, Basel and Vienna work: standups, workshops and escalations without the offshore lag.
Your language
Consultants operate fluently in German and English. Documentation and client interaction in either, audit-ready in both.
Your budget’s ally
Nearshore economics with DACH-grade delivery: more value for direct clients, more margin for consulting partners.
Onsite where it counts
Short-haul to every DACH hub for kickoffs, audits and go-lives. Onsite, hybrid or remote, agreed per workstream.
Bring us your hardest compliance problem.
No deck, no funnel. Describe your situation in a few sentences and a senior expert reads it. You get an honest answer on whether and how we can help.