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.

description:

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...

kontaktovat

contact

address

Ing. Miluše Heryšerová

+420 775 95 54 25

VAT: 08891044

info@chemikvkuchyni.cz

Nademlejnská 1069/24

Prague 9

198 00

Czech Republic

I use the following email for regulatory affairs consulting:

reg@miluseheryserova.cz