In order to enable our customers to register their end-users’ products, we have compiled a Master File (DMF) for most RENOLIT SOLMED products. The applicant’s part of the DMF is available for the registration applicant. The authorities part has been filed with the relevant National Health Authorities in many countries all over the world, including the USA. This strictly confidential part of the DMF can be used as a reference after our authorization is given.
For registration assistance world wide our Regualtory Affairs department, lead by an expert pharmacist, is at our customers’ disposal.
Most RENOLIT SOLMED formulations have been extensively tested according to the various pharmacopoeia and the elevant ISO 10993 tests. Copies of these test reports can be made available to our customers and to the final producer of the device or pharmaceutica product, to support their registration file.