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Contact

Mediteema Oy
Hemmingintie 159,
FI-37530 Lempäälä, Finland
Tel: +358-400-56 8881
Fax: +358-3-3747745
Email: mediteema(at)mediteema.com


CEO
Ritva Ylitalo-Heikkala
Tel: +358-400-56 8881
Email: ritva.ylitalo-heikkala(at)mediteema.com

Drug regulatory activities
 
We help our client in various drug regulatory activities, e.g.:
 
     -  Clinical overviews and summaries (M 2.5 and 2.7)
     -  Non-clinical overviews and summaries (M 2.4 and 2.6)
     -  Clinical expert statements (CES) for renewals and
        variations
     - CES for OTC applications
     -  Periodic Safety Update Reports (PSURs)
     -  Company Core Data Sheets (CCDSs)
     -  Summary of Product Characteristics (SPCs)
     -  Patient Information Leaflets (PLs)
     -  Literature searches
 
We also write Clinical Evaluations for medical devices (CE-marked products).