The first step to collaboration is the confidentiality agreement between the CMO/CDMO and product-owner. This is followed by the technical consultation and evaluation of technical feasibility, after which the parties enter into a contract manufacturing agreement. Then, there is a technology transfer in both directions, followed by an important testing and validation phase. Once this process is complete, contract manufacturing begins.
Operations are carried out in Karlstad, Sweden with quality services that exceed the requirements and expectations of regulatory agencies and customers:
- Registered according to ISO13485:2012 and the FDA as a Drug and Medical Device Establishment
- ESD and EX-standards, offering manufacturing of flammable products