Responsible Manufacturer for Batch Release
HÄLSA Pharma GmbH has specialised in quality management and responsibility for the manufacture of medicinal products and medical devices. Focussing on the batch release of medicinal products and the release for import of medicinal products brought into Europe, we are no 'conventional' contract manufacturer. We place medical devices on the market and perform activities relating to their certification. We are GMP consultants as well as auditors of contract manufacturers and active pharmaceutical ingredient (API) manufacturers. We also assume legal responsibilities according to the Act on Medicinal Products (AMG) and the Act on Medical Devices (MPG).
Within quality and manufacture HÄLSA assumes the responsibility of the Qualified Person, the safety officer or the quality management officer for medical devices, the medical devices consultant. Or we take on full responsibility as the formal manufacturer according to Section 3 subsection 15 MPG as well as the function of the manufacturer responsible for the batch release of medicinal products for marketing (read more) according to the German Act on Medicinal Products (Section 13 subsection 1 AMG). As a Diapharm company we provide the know-how for an efficient and uncomplicated access to the market.
Above all, HÄLSA Pharma GmbH offers complete quality management systems certified according to ISO 13485 (certificate), ISO 9001 (certificate) and GMP, including a manufacturer's authorisation (certificate). Due to the relief achieved by this service our clients are enabled to extend their product portfolio of medicinal products and medical devices quickly and efficiently - without modification of their own quality management systems.
We also help customers implement their own quality management systems in accordance with the harmonised standards ISO 9001 and ISO 13485 as well as GMP (Good Manufacturing Practice) requirements. We create the technical documentation for medical devices, coordinate all action needed for the certification of medical devices and perform conformity assessments.
Manufacturers of medicinal products also appreciate the possibility to bundle necessary GMP API audits of manufacturers of active pharmaceutical ingredients and having access to sound GMP consulting from our experienced staff. HÄLSA Pharma GmbH also offers a new, flexible alternative to medicinal product release by contract manufacturers or pharmaceutical companies that hold marketing authorisation: Our customers can commission us to take charge of batch release which is a statutory requirement for placing medicinal products on the market. We can also perform import release for medicinal products that were manufactured outside the European Union.
