ABOUT US

The Company

 

Pharma-Regist was founded in June 1990 with the aim of rendering assistance for foreign pharmaceutical companies in drug regulatory in Hungary. Some years later taking into consideration the demand of the market we started to focus on organizing and monitoring clinical trials.

Since 2004, when Hungary joined the European Union with the new expanding market and regulatory challenges, we have been participating in more and more EU registration procedures (MRP/DCP). Pharma-Regist Ltd. is committed to providing high-quality service to support the pharmaceutical and medical device industry all over Europe, therefore our team undergoes regular training to ensure compliance with applicable local laws, regulations and EU guidelines. Our aim is to ensure that client satisfaction remains at the highest levels.

 

Quality Assurance

 

We are working according to ISO 9001:2015

 

  • Regulatory Services

  • Organizing and monitoring Clinical Trials

  • Pharmacovigilance

ISO 9001 2015_HUN

 

Our Team

Vera Ruda, PharmD
Managing Director

E-mail: vera.ruda@pharmaregist.hu

Phone: +361 3187 160

Mobile: +3620 9523 726

Edit Korcsog, MSc
Regulatory and Quality Assurance

E-mail: edit.korcsog@pharmaregist.hu

Phone: +361 3187 160

  • Pharmacist

  • Since 1991 general manager of Pharma-Regist

  • Almost 30-year experience in regulatory affairs

  • 20-year experience in clinical trials

  • Since 2012 in pharmacovigilance

Katalin Wolff, MSc, PhD, MBA
MD and Scientific Associate

E-mail: katalin.wolff@pharmaregist.hu

Phone: +361 3189 787

  • Economist

  • Since 2005 at Pharma-Regist

  • Almost 15-year experience in regulatory affairs

  • Since 2012 in quality assurance

  • Since 2012 in pharmacovigilance

Krisztina Szabó, MD
Lead Clinical Research Associate

E-mail: krisztina.szabo@pharmaregist.hu

Phone: +361 3189 787

  • Biologist

  • PhD in theoretical medicine

  • MBA

  • Since 2010 at Pharma-Regist

  • More than 10-year experience in research

  • Since 2010 in clinical research

  • Medical Doctor

  • Specialization in psychiatry

  • Since 1997 at Pharma-Regist

  • More than 20-year experience in clinical trials

  • Preparation of study documentation for submission to RA/CEC

  • Monitoring

  • Project management

Árpád Hargitai, PharmD
Clinical Research Associate

E-mail: arpad.hargitai@gmail.com

  • Pharmacist

  • Since 2006 at Pharma-Regist

  • More than 15-year experience in clinical trials

  • Site selection

  • Monitoring

  • Project management

Need more information?

We are here to assist. Contact us by phone, e-mail or via our website.

© 2019 by Pharma-Regist Kft.