info@rapharm.eu

+386 1 438 16 00

Our services are tailored to indiviual needs and requirements of our clients.

raPHARM is a consultancy and education office specialising in pharmaceutical and medical devices regulatory affairs. The office was founded by Ms Vesna Koblar, MD. PhD., an internationally recognised expert in this area with extensive experience and knowledge.

Into our services, we implement a long history of working with EU institutions in the field of pharmaceutical and medical devices regulatory affairs, expert work in European Commission committees, EU Council working groups and the EMA and HMA. We have also expertise confirmed working with WHO, World Bank, EAR, EHG, ADETEF, BSI, TAIEX and on IPA projects.


We have rich experience in fields of education, consulting, outsourcing and intelligence; improving communication between competent authorities and industry; complying with EU and national requirements (in Slovenia, Croatia and SEE countries – Bosnia and Herzegovina, Macedonia (FYROM), Montenegro, Serbia) and assisting with and managing specific EU-related projects for countries approaching the EU.

Our excellent experts and assistants ensure top quality of our services.

  • Successful regulatory consultancy and services provided to over 60 companies
  • Organised over 200 educational events, seminars, courses, conferences and workshops; presented in three different languages and highly rated by participants
  • Total audience of over 4,000 from more than 150 companies from 10 different countries
  • Worked on 21 international projects across 8 different countries; bilateral or in cooperation with WHO, WB, TAIEX, PERF, EAR, EHG, ADETEF, IEP/SAA, IPA and BSI
  • Drafted 8 laws on medicinal products and 6 laws on medical devices; in total, we have written over 80 by-laws in multiple languages

Actively participated at over 120 international conferences and seminars (presentations, moderatorships…)

CONSULTING & SERVICES

Regulatory consulting, daily assistance and outsourcing services in the area of medicinal products, medical devices and food supplements.

REGULATORY INTELLIGENCE

Analysis of local requirements for marketing in the area of medicinal products, medical devices and food supplements in Slovenia, Croatia and SEE countries.

EDUCATION & TRAINING

Regulatory education and training for better understanding of EU legislation and achieving specialized skills in the area of medicinal products and medical devices.

INTERNATIONAL PROJECTS

Expert assistance for quick and reliable compliance with EU legislation and standards in the area of medicinal products and medical devices, and institutional building.

raPHARM, consulting and education, Ltd.

+386 1 438 16 00

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