for companies

regulatory affairs of medicinal products

Is your company searching for external support in regulatory affairs or does it need to compensate missing capacities of the department? I assure leading of global or local regulatory procedures. I also compile registration dossier for new marketing authorisation application, product variations or renewals. Other services based on an agreement.


  • preparation of new marketing authorisation application for national/DCP/MRP (M1 compilation)

  • variations/renewal compilation for national DCP/MRP procedure

  • preparation/compilation od eCTD dossier

  • local regulatory contact in CZ, communication with authorities

  • local pharmacovigilance contact

  • preparation of package information in accordance with the latest QRD template (CZ, EN)

  • assessment of artworks, promotional materials

  • SOP preparation

  • notification of Medical Devices

  • other...

  • White Facebook Icon
  • White Instagram Icon
  • White LinkedIn Icon



Ing. Miluše Heryšerová

+420 775 95 54 25

VAT: 08891044

Nademlejnská 1069/24

Prague 9

198 00

Czech Republic

© 2020 by Miluše Heryšerová. Proudly created with

  • Black Facebook Icon
  • Black Instagram Icon
  • Black LinkedIn Icon
This site was designed with the
website builder. Create your website today.
Start Now