Consulting and project support for carrying out quality and compliance tasks.

• Quality Assurance & Release
• Quality Management Systems
• Qualification, Validation & Verification (methods, processes, instruments, equipment and computerized systems)
• Auditing Services & Gap Analysis
• Compliance Strategy

Advice and hands-on support for meeting current regulations.

• GLP, GMP, GCP, GDP
• GAMP 5, Data Integrity Guidelines
• ISO 13485, ISO 17025, ISO 9001
• MDR, IVDR and related product standards
• GDPR

Lifecycle management support for computerized systems in regulatory controlled environments.

• Software validation
• Data Integrity Assessment (according to both EUDRALEX VOL 4 Annex 11 and CFR21 Part 11)
• Serialization
• Cybersecurity
• ERP and MES system compliance strategy
• EQMS and design of QMS architecture

We help your company to transistion, grow and succeed.

• Strategic management services merging business understanding with technical expertise and manufacturing excellence.
• Transition management and leadership services to develop, drive and secure successful change.
• Interim management services driving operational excellence and making a positive impact on your business.

Digital transformation support for your operational systems to enable your data analytics efforts and improve process efficiency.

• EQMS – enable data transparency in your compliance routines
• ERP/MES – enable data transparency between boardroom and operations
• Serialization – enable supply chain data transparency and regulatory compliance

Your complete training partner. Helping ensure your organization’s competency and skills are accurate and up to date.

• Life Science expertise
• Delivered by engaged and inspiring course leaders
• Based on real industry experience
• Available as Open, Customized or On-demand courses
• Brought to you Live or through Digital and interactive media

Our Compliance Partner program gives you access to motivated and qualified consultants – supporting you as much, or as little, as you need. You gain access to our collective expertise in a flexible and dynamic way.

Your perfect training partner. We have a wide range of courses, which can be delivered online or in the classroom. In addition to company-specific training, we also offer open courses in collaboration with Swedish Medtech, Swedish Labtech and Läkemedelsakademin.

We help you to streamline your laboratory management, work more efficiently and develop smart solutions for overcoming the daily challenges you face. We offer a complete suite of integrated lab solutions that support working in regulated environments – including the world’s most widely deployed Laboratory Information Management System (LIMS).

Accelerate your digital transformation. We help you to make optimal use of your data, to drive quicker, more informed decisions that increase the value of your operations. In addition to consulting and professional services we also offer the market’s most complete range of industry-leading solutions in this area.