Eurofins bioskin ( formely Bioskin GmbH) services

Investigation of cutaneous safety is a critical component of product development for topical and systemic products and transdermal systems. At bioskin we are experienced in the design and conduct of the entire spectra of cutaneous safety studies and offer a battery of safety tests required for assessment of products which are applied locally. In addition we plan and conduct studies evaluating systemic safety (e.g. PK or systemic absorption, ECGs, clinical chemical parameters) and histological/immunohistochemical effects.

The path to approval for generic topical products can be challenging. bioskin can help you to optimally plan and implement a development strategy: Vasoconstrictor assays according to FDA guidance: Bioequivalence of topical corticosteroids in Europe and the USA is assessed using the vasoconstrictor or human skin blanching assay as outlined in the FDA guidance. bioskin offers a competitive package for conduct of these studies together with international experts in this field.  Our exceptional team for these studies ensures that we deliver reliable, top quality results meeting agency reporting standards.

The regulatory pathway for dermatological products, in particular topically applied products, differs from those for other therapeutic indications and dosage forms. Various options of proof-of-concept designs will help you move your development programs into the best direction. Early development of proper strategies shortens timelines and reduces costs. bioskin’s in-house dermatologists can advise about clinical product development, study design, interpretation of results and the needs of dermatological patients. With our in-depth knowledge of regulatory pathways for dermatological products we also provide assistance in the preparation of and participation in scientific advice meetings.

A core expertise at bioskin is development of innovative test models for evaluation of efficacy of topical drugs and medical devices. In these models biophysical measurement methods can often be used to deliver objective data to support traditional clinical endpoints.  We customize designs for efficacy trials depending on the indication and product profile.