In the complex and tightly regulated world of pharmaceuticals, the role of the Qualified Person (QP) is not only critical—it is indispensable. Among the accomplished professionals in this field, we have professionals who stands out as a highly experienced EU-licensed QP and pharmaceutical quality expert with years of global experience across the pharmaceutical value chain.

We have successfully executed QP responsibilities at both clinical and commercial stages for a variety of product classes—including Narcotic APIs, solid dosage forms, and live biotherapeutic products (LBPs).

Proven QP Competency Across Diverse Environments: EU QP certification and batch release in line with GMP, MIA, and MA requirements.

We have deep understanding of EU legislation, ISO standards, and global compliance requirements which made us a trusted QP partner across Contract Manufacturing Organizations (CMOs), CDMOs, and in-house production units.

Our QP services are anchored in technical excellence and a proactive, solution-oriented mindset—making us a reliable partner for pharmaceutical companies aiming to maintain the highest standards of quality and compliance.

Our QP responsibilities are performed in full compliance with EU legislation, including Eudralex Volume 4 and Czech pharmaceutical law (378/2007 Sb.), ensuring that clients’ manufacturing and distribution processes adhere to the highest standards of GMP and GDP.

We provide a full spectrum of Qualified Person services:

• Batch certification and release for API and finished products
• Audit preparation and inspection-readiness for EU GMP authorities
• Implementation of CAPA, change control, and deviation systems
• Continuous SOP review and alignment with evolving regulations
• ISO 9001 audit management for integrated quality systems
• Legislation monitoring and quality oversight of warehousing and supply chain systems

Through our leadership, companies ensure readiness for regulatory inspections and uphold quality standards throughout their operations.

With our combined expertise in regulatory compliance, validation, auditing, and team leadership, we deliver Qualified Person services that are both rigorous and reliable. Our holistic view of pharmaceutical quality systems and hands-on approach make us a trusted partner for ensuring regulatory compliance and maintaining product integrity throughout the manufacturing lifecycle.