HÄLSA Pharma GmbH is a manufacturing and batch release company for medicinal products and a qualified manufacturer of medical devices. We test and approve clinical trial samples and medicinal products for EU import and market release in accordance with legal requirements and the EU Good Manufacturing Practice guidelines.
With our help, distributors can expand their product portfolio with medicinal products or medical devices without the need to adapt or make extensive changes to their own Quality Management systems. We are optimally prepared to perform this role and pride ourselves on the responsible conduct of these duties. HÄLSA tests product quality in line with legal requirements, conducts audits of contract manufacturers and active pharmaceutical ingredient suppliers, and ensures that all products released to the market are safe and conform to the applicable standards.
As a manufacturing and batch release company for medicinal products in accordance with Directive 2001/83/EC and as a qualified manufacturer of medical devices we are by your side throughout the entire process, up to the first marketing authorisation and throughout the product-lifecycle and beyond. Our Quality Management system is certified according to Good Manufacturing Practice (GMP) and EN ISO 13485.