Regulatory Affairs

Pharmaceutical department that aims to guarantee the protection of public health by ensuring the efficacy and safety of medicines for human and veterinary use, medical devices, cosmetics, and food supplements.

ZEMIR PHARMA CONSULTING provides a complete regulatory service with the highest degree of rigour and specialisation, from placing medicine on the market to making the necessary changes to the terms of the marketing authorisation, so that it is always kept up to date and marketed under the legislation and standards in force.

 

Marketing Authorisations

• National Procedure
• Mutual Recognition Procedure
• Decentralised Procedure
• Centralised Procedure
• Outlining strategies for obtaining marketing authorisations
• Review and preparation of application dossiers
• CTD, eCTD format publishing
• Medical writing - Expert reports

 

Maintenance of Marketing Authorizations

• Type IAin, IA, IB and Type II variations
• SmPC, PL and Labelling (QRD template) elaboration and review
• Marketing authorisations renewals
• Marketing authorisations transfers

 

Review and notification of advertising material

Event notification – transparency and advertising

Package Leaflet Readability tests

Package Leaflet Bridging studies