We are GMP & Compliance experts
Our team of experienced GMP consultants and engineering provide expert advice on quality management, manufacturing solutions, and processes within GxP-regulated.
We specialize in GMP-regulated manufacturing environments. Our capable and highly experienced GMP consultants provide expert advice on quality management, production, and processes within GxP-regulated environments.
Eltronic’s extensive experience with both GMP as well as manufacturing it and automation make us a preferred supplier of services and solutions within the medical device and pharmaceutical domains. We offer specialized know-how in the fields of concept development, design, and implementation of pharmaceutical production systems.
In recent years, it has been legalized to produce medicinal cannabis in Denmark. Since the approval, Eltronic A/S has helped companies with their application for facility licensing and production permits. We have assisted start-ups as well as facilitated international pharmaceutical business expansions, through providing GMP (DK/EU) compliance consultation in areas of data integrity, seed-to-product batch tracing, cleanroom validation processes, facility design, and employee training services.
As an example, our team has developed and implemented Quality Management Systems (QMS) for new facilities for the production of medicinal cannabis herb starting material (API), as well as facilitated successful audits from the Danish Medicines Agency (DMA).
Using our experience and knowledge, we can design and develop your QMS to fit your current needs and your planned expansion; including the current legislation, GACP guideline, acts, and orders on euphoriant substances from DMA. Our team consists of experienced regulatory compliance consultants, project managers, system designers, and automation architects, which ensure the development and implementation of automated – and data acquisition systems within a GMP-regulated area. All automation is developed and tested according to GAMP5 guidelines.
Your one-stop-shop with hands-on experience
At Eltronic A/S, we make it possible for you to get your production approved and started. We offer consultant resources that can work within your organization and integrate into your existing team. Furthermore, we can ensure the design and implementation of complete QMS or automated solutions that help you achieve design efficiencies, regulatory compliance processes (incl. procedures), and mandatory employee/contractor training.
Hear more about our experience with medicinal cannabis production and how we can help you.
We help our customers with all aspects of quality management and GMP compliance and processes.