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 provide services either as stand-alone services, or as consultancy services for a longer period.

In addition we have a thorough knowledge of registration processes and strategies. We are highly experienced in the legislation of pharmaceuticals, medical devices, cosmetics and foods. We have contributed to the development, registration, and maintenance of many safe and qualitative excellent products. We have participated in discussions concerning the classification of OTC products, since it is not always obviously clear which legislation (pharmaceutical, medical device, cosmetic or food) applies to an OTC product. Moreover, we have advised in determining the most convenient regulatory affairs strategy.

Currently, the main focus of our activities is the writing and the submission of documents present in the registration files of pharmaceuticals and in the Technical Files of medical devices according to the applicable laws and guidances. The last years, we received many questions for writing CERs, PMCF reports, and BSERs for medical devices which needed to be upgraded to the MDR.

In all those years we have pleasantly cooperated with formulation technologists, manufacturers, analytical laboratories, and distributors in order to facilitate product development and to ensure the maintenance of products on the market.

Please contact us if you want to receive more information.

Kind regards, Yvonne van den Eijnden