GMP & Compliance

Complete production automation often demands an alliance of companies – we provide it all: mechanical, software integration, process optimization, compliance, and beyond.

We’ve got your production covered

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.

Core competences:

Automation of both process and discrete engineering
Robotic and Mechanical Engineering
Installation Services including Electrical and Panel Solutions
MES, Scada, FMS & BMS Engineering
Quality control and compliance
Consultancy

Serialization

To meet the next wave of increasing requirements to traceability, we have developed inline modular and scalable serialization solutions which include a mobile printer station for serialization and aggregation. The solutions meet all EU and US requirements and come in both a manual and a semi-automatic version.

Medicinal Cannabis

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.

Medical Cannabis production

Hear more about our experience with medicinal cannabis production and how we can help you.

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Your one-stop-shop partner

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 consider all aspects

We always consider all aspects of a process or production to ensure optimized and integrated solutions.

We make complex simple

We always aim at making things simple and eliminating all redundant processes.

We are specialists

We help our customers with all aspects of quality management and GMP compliance and processes.

Our GMP-controlled markets:

Devices
Fill and finish pharmaceutical manufacturing
API production
Biotech
Packaging

Our services:

Risk and change management
Project planning and execution
QP/QA/QC services and clean-up projects
Audits and inspections
Training and coaching
Troubleshooting

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Process Automation

Eltronic A/S is one of the largest automation companies in Denmark, and we have developed process automation solutions for our food & beverage, life science, and other industries customers throughout the last 20 years.

Eltronic A/S

Eltronic A/S is an ambitious engineering company with more than 20 years of experience developing production systems and automation. Our goal is to be our customers’ preferred partner and to increase their global competitiveness and sustainability.

Contact us

Eltronic A/S, Hedensted
Kilde Alle 4
DK-8722 Hedensted

Eltronic A/S, Ballerup
Brydehusvej 30
DK-2750 Ballerup

Eltronic A/S, Odense
Forskerparken 10
DK-5230 Odense M

Eltronic A/S, Horsens
Erhvervsbyvej 4
DK-8700 Horsens

CVR: DK-17 02 42 80