In the field of Biologics, IDT Biologika focusses on the manufacturing of sterile, injectable large molecule products, including packaging. We offer services from clinical phase II/III to the large scale commercial manufacturing of vials, pre-filled syringes with and without safety device, the auto injector assembling as well as several packaging formats. Our manufacturing platforms provide GMP compliant end-to-end services in BSL2 facilites meeting EMA, FDA and ANVISA standards.
Process characterization and Validation
Development of Client Specific Methods
Method Validation (ICH)
Preparation of CMC Documents