Medical devices are used to diagnose, prevent, monitor, treat or alleviate a disease by means of a physiological way of action. Medical devices in Europe must comply with Regulation 2017/745 (MDR) or the European Directive Directive 93/42/EC (MDD). The certification procedure of a medical device is dependent on the classification of the involved product and usually (except for class I medical devices) a Notified Body approves the application.
... Read More ...Pharmaceutical products (also called drugs, medicines, or medicinal products) are used to diagnose, cure, treat, or prevent diseases by means of a pharmacological way of action. Pharmaceutical products in Europe must comply with the European Directive 2001/83/EG. The registration of pharmaceutical products can usually be done via national or MRP/DCP procedures. After finalization of a registration procedure the pharmaceutical dossier must be maintained and kept up-to-date according to the applicable rules.
... Read More ...Cosmetics are used to clean, perfume, change the appearance, protect or correct the body odours of skin, hair, nails, lips, teeth and mouth. Cosmetics in Europe must comply with the European Regulation 1223/2009. Manufacturers are obliged to have a Product Information File (PIF) available on demand and a cosmetic product must be notified in the CPNP database when placed on the market.
... Read More ...
Welcome to the website of YES Pharma Consultancy B.V. which has been founded in 1999. Through all those years we have been a reliable, flexible, and enthusiastic partner for many companies in the Over The Counter (OTC) market. We have offered a wide range of services in Regulatory Affairs. We have contributed to theRead the rest of this page »
