The implementation of the Medical Device Regulation in 2021 results in an increased demand for clinical trials with aesthetic dermatological products such as fillers. Through the strategic cooperation with the dermatological practice 'Prager & Partner' we create the conditions to successfully serve the increased demand of our customers in this field.
Clinical testing of aesthetic dermatological products
- Category
- Medical, SGS proderm
- Date
- Share
Many products in the field of aesthetic dermatology, such as filler preparations, are considered to be products without a medical purpose, the marketing authorization for which must be granted in accordance with the requirements of the MDR and must therefore be based on clinical trials. Botox preparations also remain in focus. These are tested according to the guidelines of the AMG. We offer corresponding studies in cooperation with our partner.
Within the scope of this cooperation, proderm on the one hand assumes the role of CRO, i.e. we competently support our customers as the first point of contact and take over all pre- and post-trial tasks. In addition, as an excellently equipped site, we provide our resources, such as premises and equipment, for the actual execution of the study, which is carried out jointly with the involvement of the specialists from "Prager und Partner".
Extended range of services, familiar quality
The cooperation allows us to expand our range of services in a business field that is currently characterized by increased demand due to regulatory requirements. "With the specialists from "Prager und Partner", we are able to expand our services in the field of aesthetic dermatology while maintaining our high quality standards and position ourselves even more strongly as a competent full-service provider in the future," says Marianne Brandt, COO of proderm.
In most cases, the studies on our side are managed by our medical team. Dr. Alexandra Erlach and Nina Lu are available as contact persons.
About 'Prager und Partner'
Dr. med. Welf Prager is one of the leading German dermatologists in the field of dermatosurgery and a pioneer in gentle aesthetic medicine. After many years as a senior physician at the Dermatology Clinic at Klinikum Kassel and as a partner at Dermatologikum Hamburg, he opened his own practice, Prager & Partner, in the Elbe suburbs of Hamburg in 2014. Here he performs treatments such as wrinkle treatments with Botox, hyaluronic acid and fillers, lip treatments, nose corrections and surgery-free facelifts. Today, the company also includes Prager Derma, the department of medical and dermaceutical cosmetics. Cosmetics in close cooperation with medicine offers effective treatment procedures that go far beyond the usual level of cosmetics and provide visible results.
