- Coralex s.r.o. - Regulatory Affairs Consultants - Bratislava, Slovakia

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MEDICINES

REGISTRATION

-   Compilation of registration dossiers
-   Product material translations (SmPC, PIL     and Label)
-   Filing application with the authorities     (national, MRP and decentralized procedures)
-   Coordination during the registration process
-   Follow-up with the respective authorities
-   Life-cycle management including Variations     and Renewals
-   Other modifications


PRICING AND REIMBURSEMENT

- Compilation of reimbursement files
- Application to the authorities
- Coordination and follow-up during the approval   process
- Following-up on development and changes in   the reimbursement list and taking appropriate   actions to reflect these changes

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