As an experienced provider of products for regenerative medicine and tools for cell therapy applications, Miltenyi Biotec caters to our customers’ needs with technical and regulatory support and long-term perspectives.
Type II Master File or Safety Master File (for cross-reference) for select MACS® GMP Products
Worldwide (ex USA)
Regulatory Support File (equivalent to Master File, for cross-reference)
Company Information and Quality System
Self Survey and Customer Questionnaires as part of a customer vendor qualification program
Miltenyi Biotec actively interacts with regulatory agencies and notified bodies. Please ask us about customized support for your clinical study.