Market Manufacturer

Production, manufacturing or production? The manufacture of medicinal products and medical devices is not a purely technical Act. This realization can reduce costs! For consumers, it seems clear: manufacturer is the one whose brand name is on the product. This produced but often not itself: as a Distributor, he leaves it a contract manufacturer. So far, so clear. In the drug and medical device law, however: manufacturer is the one who releases the product for traffic or brings into circulation. And it can be quite useful if someone is neither distributor nor contract manufacturer.

The companies in the food, pharmaceutical and cosmetic industries are looking for that can usefully expand its portfolio and complete always new products. Poking them in finding deeper in the fast-growing field of health care AIDS before to over-the-counter disillusionment spreads often (OTC) medicines or medical devices around. To fulfilling regulatory requirements and quality standards in an area that does not count the core competence of the company, such product ideas can be quickly unprofitable work. Here, everything is a question of – in this case between sales, production and production. The requirements for a permit for the placing on the market of medical devices or drugs are clearly regulated by EU directives and national laws. So, higher medical device manufacturers have since July 2006 EN ISO can demonstrate, for example, the quality standard DIN 13485:2003.

A cosmetics company that so, for example, have a product portfolio to a single medical device, teeth whiteners, wants to expand, is suddenly before a significant certification effort. Moreover, the time-to-market of a new product through the necessary modification of the existing quality management system extends sensitive. Similar is true, for example, medical device manufacturers, who want to take on a medicinal product or a combination product for strategic reasons in the portfolio: as a manufacturer they should since the 14. Amendment to the medicines Act of October 2005 release each individual product batch by their competent person usually a tenured pharmacists with appropriate experience can be. In addition, that the food, their own regulatory requirements apply to pharmaceutical, medical devices and cosmetics. Only a few companies are likely to have an interest to superimpose their established organizational structures for the core area with additional regulatory requirements for only an additional product. Some of the contract manufacturer take over the tasks and the required regulatory activities for the placing on the market. The outsourcing of manufacturing, packaging and inspection activities helps to save expensive production facilities on sites of distribution operator and best utilize the equipment side of the wage paver. Economies of scale can be used optimally by both sides.