The Life Science industry is characterized by the need for compliance with regulatory requirements, traceability and transparency. At the same time, the industry has to consider new requirements for small batch sizes, fast product development and production flexibility.
At Eltronic, we have a team of experts who specialize in GMP-regulated manufacturing environments. Based on many years of experience with the industry, our team is able to provide expert advice on quality management, production and processes within GxP-regulated environments. Our GAMP V experts can offer IT and automation solutions tailored to the Life Science industry.
We work with the following GMP-controlled markets:
- Fill and finish pharmaceutical manufacturing
- API production
Case: Device to medicine
For a product release to a south pacific market, Contura International needed to change the status of a medical device to veterinary medicine. Reduced costs, increased speed to market and a project plan based on GAP analysis and former reports were some of the major requirements. Based on Eltronic’s experience with QMS, LEAN and project management, Contura turned to Eltronic for the GMP transformation of the project. Eltronic has been appointed qualified person (QP) for the ongoing drug release.
Pharmaceutical transformation project
Director, Pharma Engineering