Full service for medical devices and medicinal products GMP

HÄLSA Pharma GmbH is a manufacturing and batch release company for medicinal products and a qualified manufacturer of medical devices. Operating at the interface between production and distribution, HÄLSA guarantees the safety of pharmaceutical products.

We are committed to responsibility

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.

Release services for medicinal products and medical devices

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 in accordance with the Medical Devices Directive (93/42/EEC) 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.

HÄLSA Pharma GmbH is a Diapharm company.

Certificates for download

ISO 13485 certificate (click to download)
Manufacturing authorisation (click to download)
GMP certificate (click to download)

Get in touch with us!

Our service hotline:+49 251 60935300