“Our services encompass the full range of expertise needed to bring your product from the lab to the market. Our Leadership Team supports you in all interactions with the scientific or investor community.”
– Franziska Stemmler, Customer SolutionsSend an inquiry
Need help with setting up your ISO 13485:2016 certified Quality Management System? We offer in-house and licensed solutions.
Upcoming regulatory inspection at one of your manufacturing sites? Slow enrolment in a clinical trial? Our senior auditors have a hands-on approach to resolve all issues.
We support you from the compilation of your IND all the way till NDA/MAA/PIP submission, with obtaining scientific advice as well as writing, publishing and submitting your eCTD dossier.
Need a medical evaluation of your project? Require a medical monitor to assess Safety Events or liaise with clinical investigators? Our in-house physicians and dentists understand your project.
CLINICAL TRIAL MANAGEMENT
We’ve successfully planned, submitted and conducted clinical trials with thousands of patients in virtually every region of the world.
Document and Data Management
Setting up secure data rooms, managing collaboration websites with >1M documents, implementing eQMS, eCRFs and eTMFs?
We’ve done it.
CHEMISTRY, MANUFACTURING & CONTROL
Whether small molecules or biologics, our CMC experts will manage your most challenging projects from start to finish.
Training and Workshops
Need to update your team’s skills in a particular topic? Looking for a central location to organize a KOL meeting? We’ll take care of it, letting you focus on the important matters.