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:
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preparation of new marketing authorisation application for national/DCP/MRP (M1 compilation)
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variations/renewal compilation for national DCP/MRP procedure
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preparation/compilation od eCTD dossier
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local regulatory contact in CZ, communication with authorities
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local pharmacovigilance contact
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preparation of package information in accordance with the latest QRD template (CZ, EN)
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assessment of artworks, promotional materials
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SOP preparation
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notification of Medical Devices
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other...
contact
address
Nademlejnská 1069/24
Prague 9
198 00
Czech Republic
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