Reimagining compliance through intelligent, human-centered AI.
Your expert in IT Quality & Compliance for the regulated industries
Reimagining compliance through intelligent, human-centered AI.
About Qualitice - Your AI-first Partner for Life Sciences
Qualitice is a dynamic consulting agency for IT Quality & Compliance within the Healthcare industry. We are an AI-first consultancy: we combine regulatory expertise with AI-driven tools to accelerate compliance, ensure data integrity, and optimize digital transformation in life sciences. The company caters for industries that need to follow strict regulations like biotech, chemicals, drugs, and medical devices.
Qualitice is building the next-generation validation and compliance consultancy: one where deep GxP expertise is amplified by intelligent AI agents that automate the heavy documentation burden and strengthen regulatory alignment.
We don’t replace experts with AI. We empower them. Our consultants deliver strategy, governance, and quality leadership, while our AI agents accelerate documentation, risk assessments, validation plans, and audit preparation, ensuring compliance is fast, consistent, and inspection-ready.
This hybrid model creates unique value: industry-leading consulting with the power of compliant AI co-pilots. Our vision is to transform how life-science companies validate systems, prepare for audits, and manage compliance blending trusted human judgment with intelligent automation.
Our services include:
- Computer System Validation/ Computer System Assurance according to GAMP 5 (2nd edition) and regulatory requirements (FDA part 11, Annex 11, Annex 22)
- Audit Execution and Preparation / Regulatory Compliance within Pharmaceuticals and Medical Device industry
- Business and IT assessments Strategy and advice on quality, validation and compliance
- Requirement Engineering Global and local SOP Creation, Review & Approval Data Integrity Strategy & Gap Assessment (ALCOA)
Our Approach Qualitice is flexible in the provision of its services, depending on your needs; either on-site, remotely, or a combination of both.