HB Medical ensures all aspects related to contract manufacturing for their clients; from custom production of substances and products to the ordering and shipment process. This is a great advantage as they have the manufacturing facilities needed to produce the finished goods.
At HB-Medical they offer services relating to product development and their involvement extends from advice relating to initial development, tests, primary and secondary packaging material, to shipment. At HB-Medical they do not offer any standard solutions every solution is developed bottom up.
The company is approved by the European Health Authorities through The Danish Medicines Agency which inspects HB-Medical processes and facilities on a regular basis. The authorization (section 39 of the Danish Medicines Act) allows HB-Medical to manufacture Human and Veterinary medicinal products both for the market and for clinical trials and to import from medicinal products from countries ouside the EU. Moreover HB-Medical has been awarded a license by the Danish Veterinary and Food Administration (DVFA).
Services:
Contract Manufacturing
HB Medical ensures all aspects related to contract manufacturing for their clients; from custom formulation of substances and products to the ordering and shipment process. This is a great advantage as they have the manufacturing facilities needed to produce the finished goods.
At HB Medical they offer services relating to product development and their involvement extends from consultancy related to initial development, tests, primary and secondary packaging materials, to supply. At HB Medical they do not offer any standard solutions, every solution is developed bottom up.
Consultancy
Their company consists of professionals who are specialized in Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and Clinical Supply Management. Also they are competent in several languages and can act as Qualified Persons (QP), which make them able to accommodate all different types of clients with preparation of documentation and advice in quality assurance, clinical trials, logistics and supply.
Biotech Services
HB Medical has experienced a rise in demand from biotech and pharma companies relating to handling of non-core services such as Active Pharmaceutical Ingredients import from 3rd countries, storage, and more. HB Medical offers a wide range of GxP services to their customers under their authorization under the Danish Medicines Act.
One of their tailor-made services consists of formulation, packaging operations and logistic solutions related to clinical trials. They offer distribution of investigational medicinal products where all regulations are taken into account accordingly. Here they also provide the necessary Qualified Person services including batch release.
