40+ jaar expertise in laboratoriumapparatuur
Service & onderhoud door gecertificeerde specialisten
GxP consultancy for Pharma, Biotech and Medical Devices
Yxion helps clients in the Pharma, Biotech, Food and Medical Devices sector to innovate and improve processes, equipment, environments and services. As a partner in the Pharma Alliance, Yxion offers independent GxP consultancy for all GDP-related challenges.
Yxion is a consultancy firm that supports clients in the Pharma, Biotech, Food and Medical Devices sector in innovating and improving processes, equipment, environments and services. Yxion consultants possess a wealth of practical experience and theoretical knowledge at the intersection of GxP regulations, engineering and quality assurance.
What sets Yxion apart is its discipline group structure: every consultant is a member of one of three discipline groups (Quality Assurance, Engineering & Project Management or Commissioning & Qualification). When a client engages one Yxion consultant, they in practice gain access to the combined knowledge of all three discipline groups.
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Yxion offers three core solutions for clients in the pharmaceutical sector and related industries.
In the pharmaceutical industry, GMP and GDP guidelines are the backbone of quality and compliance management. Yxion helps companies set up quality management systems, conduct gap analyses, guide CAPA processes and prepare for inspections by regulatory authorities such as the MHRA, EMA or FDA. Consultants are fully up to date with the latest guidelines, including EU GMP Annex 1 and ICH Q10.
Yxion's Engineering & Project Management discipline group supports the technical specification of installations and supervision of realisation projects. The Commissioning & Qualification discipline group handles IQ/OQ/PQ qualifications of equipment and spaces, validation plans and validation dossiers. This is particularly relevant when installing new laboratory equipment from Poly Temp Scientific in a regulated environment.
With the introduction of the EU Medical Device Regulation (MDR), medical device companies face extensive compliance challenges. Yxion supports manufacturers in implementing MDR requirements, conducting clinical evaluations, setting up post-market surveillance systems and communicating with notified bodies. All consultants are up to date with the current state of MDR implementation and HACCP requirements for food contact materials.
Quality Assurance, Engineering & Project Management and Commissioning & Qualification: one Yxion consultant brings the knowledge of all three discipline groups to your project.
Yxion consultants are up to date with the latest guidelines on GxP, MDR and HACCP and can provide a suitable answer to every compliance challenge.
As an independent consultancy firm, Yxion provides objective advice focused entirely on the client's interests, without ties to suppliers or products.
Yxion thoroughly prepares clients for inspections by regulatory authorities such as the MHRA, EMA and FDA, including mock audits and gap analyses.
Yxion handles complete qualification processes for equipment and spaces, including drafting URS, DQ, IQ, OQ and PQ protocols and the associated reporting.
Yxion serves clients across four sectors: Pharma, Biotech, Food and Medical Devices. This broad coverage makes Yxion a versatile partner for complex multi-sector projects.
Many clients of Poly Temp Scientific operate in a GxP environment and require independent advice on compliance, validation and qualification of their equipment. Yxion offers precisely that expertise. Through the Pharma Alliance, equipment procurement and the associated GxP guidance can be arranged in one coordinated process.
Within the Pharma Alliance, Yxion works closely with partners such as Dyzle for temperature validation and PMT Benelux for measurement instruments and cleanroom validation. This creates an integrated approach in which each discipline is covered by a qualified specialist.
The pharmaceutical industry operates in one of the most regulated environments in the world. GMP and GDP guidelines, MDR requirements and HACCP standards place high demands on processes, equipment and documentation. Organisations that fail to keep pace risk inspection findings, production downtime or market withdrawal. Yxion helps clients remain proactively compliant by bringing the right knowledge and experience to the right point in the process.
Do you have questions about GxP compliance, validation or audit support for your pharmaceutical organisation? Get in touch for a no-obligation consultation.
Yxion is one of fifteen specialised partners in the Pharma Alliance. Discover the full network.
Do you have a project involving multiple disciplines? Our advisors are happy to explain how the Pharma Alliance can support you with an integrated approach.
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