Who we are

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

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

Our experience up to date

  • 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…)

raPHARM, consulting and education, Ltd.

30 Miklošičeva Street
SI-1000 Ljubljana
Slovenia, EU

E info@rapharm.eu
T +386 1 438 16 00

Testimonials

»raPHARM – experts in their field, a power of enormous personal experience shared with accuracy, grace and flexibility of true professionals. They carefully navigate through regulatory requirements to provide valuable advice and direction, demonstrating their experience and commitment.«

ALKALOID AD SKOPJE, Macedonia (FYROM)

»raPHARM offers a unique form of training and information delivery in EU pharmaceutical and medical devices regulation. They have proven to be a valuable partner, especially to new institutions such as CALIMS. It is clear that their team of experts led by doyen of EU regulatory affairs Dr. Vesna Koblar are leaders in their fields. Their presentations and workshops enable vital interaction between regulatory authorities and industry. After attending various seminars and workshops, we saw direct efficiency improvements in our workplace. We look forward to this successful partnership continuing.«

CALIMS (Agency of medicines and medical devices), Montenegro

»We have been co-operating with raPHARM for a while and they have always performed their services with precision and professionalism. They have provided us with incredible support and guidance through demanding local regulatory requirements and specifics in Slovenia and SEE countries. Furthermore, helping us connect with suitable local business partners made our market penetration a great deal easier and secure.«

EMERGOPHARM, Poland