QA
Services
Rooted in Expertise. Built for Compliance.
Quality Assurance (QA) plays a central role in ensuring compliance and maintaining process reliability. With over 10 years of hands-on experience in GMP, GDP, MDR, ISO13485, ISO22000 and other international standards, we help companies developing, implementing, and maintaining QA systems that make sense and are aligned with regulatory expectations.
Whether you need interim QA support, full-scale implementation of a Quality Management System, or assistance addressing compliance gaps, we make sure your quality operations are efficient, fully compliant and future-proof.
Why choose us?
Industry experience
With 10+ years of operational QA experience, we’ve worked across both distribution and production environments, supporting companies in the pharma and other life sciences sectors. We don’t just blindly follow regulations, we understand them and apply them strategically, ensuring compliance is both complete and appropriately integrated into your business operations without the unnecessary complexity.
Tailored, Analytical and Tech-Enabled
We ensure that the solution fits your business needs by listening first.
Additionally, “What does the data say?” is often overlooked when addressing complex issues. Where applicable, our guidance is supported by data analysis. These capabilities go beyond spreadsheets, using code (mainly Python) to analyze large and complex datasets to uncover insights that lead to smarter decisions.
End-to-End QA Services
From training junior QA staff to preparing for GMP, GDP, HACCP, ISO13485 or any other QA related audits, we help you maintain or scale your quality system. We provide fully outsourced QA support or team extension with expertise and fresh insights, ensuring continued compliance even during temporary absences.
Our core services.
QA-as-a-Service
Every business has unique Quality Assurance needs. Whether you are looking to outsource QA management, or need support regarding specific elements of your QMS, we’re here to help.
Services include, but are not limited to:
Training: On specific topics (for example periodic GMP/GDP refreshers) or complete outsourcing of your training management.
Audits: Both internal audits and supplier audits worldwide.
Backlog resolution: A temporary extra set of hands to resolve backlogs on deviations, complaints, CAPA’s and Change Controls.
Document management: Creating, reviewing and maintaining your documents and records in accordance with Good Documentation Practices.
Supplier & Customer qualification: Continuously maintaining your supplier and customer qualification status.
Validation & Qualification activities: For equipment, premises, processes or computerized systems.
Compliance management support: Avoid Regulatory Action by acting now.
Have a specific activity in mind but it’s not listed? Let us know what you’re looking for and we’ll get back to you within 24 hours.
Fast-Track QMS Setup
Speed is crucial when setting up a QMS. We’ll guide you through a rapid, yet thorough, process to get you certified as fast as possible.
How we work:
Phase I. Development of essential documentation:
Based on our templates (that were challenged in past inspections) as a starting point. These are further tailored in close collaboration with your Subject Matter Experts.
Phase II. Training of staff & Implementation:
Training is a very important element for the success of your QMS. Not just to pass the inspection but also to ensure your company’s operations.
Phase III. Continued support:
Our collaboration doesn’t have to end once you’re certified. We provide ongoing support to help you maintain and continuously improve your QMS.
Let's navigate QA together.
Our role is to help you confidently manage risks and meet regulatory expectations with long-term vision. In close collaboration, with modern tools and a results-driven mindset, we provide support in every step of your QA journey.
Get in touch to discuss how we can strengthen your quality system and support your team.