Do you need a medical evaluation of your project? Or do you require a medical monitor to assess Safety Events?
Our in-house physicians and dentists understand your project.send an inquiry
“Our leadership team supports you in all interactions with the scientific or investor community. You can depend on our expertise to bring your product from the lab to the market.“
– Franziska Stemmler, Customer Solutions
CHEMISTRY, MANUFACTURING & CONTROL
Whether small molecules or biologics, our CMC experts will manage your most challenging projects from start to finish.
Are you planning to set up your ISO 13485:2016 certified Quality Management System?
We offer in-house and licensed solutions.
Document & Data Management
Setting up secure data rooms, managing collaboration websites with >1M documents, implementing eQMS, eCRFs and eTMFs?
CLINICAL TRIAL MANAGEMENT
We’ve successfully planned, submitted and conducted clinical trials with thousands of patients in every region of the world.
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.
From upcoming regulatory inspection at your manufacturing site to slow enrolment in a clinical trial…
Our senior auditors have a hands-on approach to resolve all issues.