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WHO WE ARE
Thursday, 18 July 2013 10:34

PharmaKos d.o.o. company Zagreb, specializes in providing regulatory consulting in the field of medical and pharmaceutical sciences.

The name PharmaKos symbolically combines the main service of the subsidiary office, related to medical products (Greek Pharmakon = medicine; Pharmacos is a database of European Union legislative guidelines for medical and biotechnology products) and the family name (of the owner).

Services provided by PharmaKos are as special as the flower of endemic plant Degenia velebitica, which the blackbird featured in the company logo carries in its beak.

 
SERVICES
Thursday, 18 July 2013 09:58

-       Representation

o   PharmaKos provides services of representation for both domestic and foreign companies in the area of Republic of Croatia, dealing with manufacturing and/or trading of medical products and medical devices

-        Primary contact toward regulatory authorities on behalf of the client

o   Agency for Medical Products and Medical Devices (ALMP)

o   Ministry of Health of Croatia

o   Croatian Institute for Health Insurance

o   Croatian National Institute of Public Health

o   State Office for Radiation Protection

-       Obtaining marketing authorization for medical products / medical devices / cosmetics for medical use / food supplements on behalf of the applicant (holder of the authorization)

o   Preparing the application dossier for submittal to authorities (CTD; EU format)

o   Handling certified translation required for the application

o   Continuous monitoring of the registration process at the ALMP until the registration certificate is obtained

-       Setting up and monitoring clinical trial applications for both medical products and medical devices on behalf of the client (holder of previous approval )

o   Preparing and reviewing the application dossier

o   Handling  translation of documentation related to clinical trials

o   Continuous oversight of the clinical trial approval process (Central Ethics Committee, Ministry of Health and Social Welfare)

o   Regulatory control throughout the course of the clinical trial

-       Selection and organization of storage and distribution of goods from licensed wholesaler companies in the Republic of Croatia

-       Services related to the local responsible person, holder of the pharmacovigilance license

 

-       Marketing of medical products and medical devices

o   Preparing/reviewing advertising materials

o   Preparing and organizing promotional activities at seminars and congresses

o   Organization of professional seminars ( schools )

o   Field training of medical representatives

-       Assistance and consulting related to the organization of business regarding Quality Assurance (ISO certificate-oriented); preparing Standard Operation Procedures (SOP) tailored to wholesalers of medical products and medical devices, and also contracted research organizations, as well as local dealers of medical products and medical devices…

 
SPECIALTIES
Thursday, 18 July 2013 09:54

-       Preparation /evaluation of IMPD quality documentation

-       Expertise in biotechnology products (vaccines, blood derivatives, GMO medical products)

-       Regulatory support in setting up clinical trials and registration procedures in the European Union

-       Expertise and experience of the responsible person for wholesale

-       International expertise in setting up and using the database for side-effects monitoring 

 
ACHIEVEMENTS
Thursday, 18 July 2013 09:34

-        First person from the Republic of Croatia accepted as a student at the prestigious postgraduate course in regulatory affairs at the University of Cardiff, UK

-        First person in Croatia to receive approval for a clinical trial on a GMO medical product, by personally presenting the project in front of the Central Ethics Committee

-        First person in Croatia to receive approval for registering „borderline“ products in the medical product inquest register.

 
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