MEDEA PHARM s.r.o.

 

 

 

 

MEDEA PHARM   s.r.o.  is  a  company  registered  in  the  Czech Companies’  register  of   the  Regional   law court in  Brno under

the identification  No.  25 569 643  (File mark: C.  34443).  VAT: CZ25569643. Address: Srbská  46, 612 00 Brno, Czech Republic.

Tel.: +420-724 296 960. E-mail: <medea@medeapharm.com>

 

 

 

 

 

 

 

       Before SUBMISSION OF APPLICATION FOR REGIS­TRATION OF YOUR PRODUCT WE OFFER:

 

 

 

 

 

 

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business and regulatory strategy for the territory

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dossier review for registration

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compiling pharmaco-toxicological and clinical expert reports in CTD format according to rules governing medicinal products in the European Union

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preparing translation of SPC and user leaflet and labeling into Czech language 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

DURING REGISTRATION PROCESS WE OFFER:

 

 

 

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representing your company before the regulatory authorities

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handling of the application from submission to ap­proval

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answering to deficiency letters, renewals, mainte­nance

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liaison with State Institute of Drug Control in all stages of the procedure

 

 

 

post-authorization services:

 

 

 

 

 

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producing  documentation for scientific marketing

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medical writing

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organizing of scientific symposia dealing with the product

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promoting your product on university clinics

and hos­pitals

 

 

 

 

THE QUALITY OF OUR SERVICES IS GUARANTEED BY MEDEA PHARM’S MANAGEMENT:

 

 

 

Jarmila Sládková, M.Sc.  has many years experience in medical and industrial research and marketing as well as in business and business policy management of pharmaceutical company.

 

 

 

Tomáš Sládek, M.V.D., Ph.D.  has worked in the area for many years with a proven record of medical research and university teaching as well as long term experience in position of medical/science manager for pharmaceutical industry.