Integral Solutions in Regulatory Affairs and Approvals of Sanitary Registrations.
For this reason, we want to be your best partner when it comes to registering your medical devices, & services, and introducing them quickly and effectively to the market.
We are your Best Partner in Sanitary Registrations
At BRAYSER, we help you perform and obtain the following documentation:
- Sanitary Registrations of Medical Devices (Class I to III)
- Administrative / Technical modification
- Sanitary Import Permit
- Sanitary Registrations of Drug Products (Generics and New Molecules)
- Submitting diverse procedures in COFEPRIS (e.g. Establishment Notifications)
In BRAYSER, we are very aware of the need and the complexity to obtain or renew the Approvals with COFEPRIS.
We always seek to favor the client in the temporal and economic aspect, without leaving aside the legal framework required.
We work with the three equivalence agreements:
We design the Regulatory Strategies according to the risk classification, product grouping, and we ensure it is the better option for the client, both in time and resources.