Obtaining and maintaining marketing authorisations and registrations is a challenging and time-consuming process, which is subject to strict regulations and governed by different laws. The national and international requirements European Pharmacopoeiaare increasing and are changing at an increasingly rapid pace. To stay up to date requires continued commitment.

In our Regulatory Services Department, competent employees with long-term experience are responsible for our medicinal products, medical devices and food supplements during their complete life cycle:

  • Support of product development
  • Writing of documents for authorisations and registrations
  • Dossier creation and maintenance
  • Preparation and implementation of submissions with authorities
  • Packaging material – Artwork Management
  • Pharmacovigilance, post market surveillance

Our team offers this expertise also to our customers.

Submissions in eCTD-format and maintenance of data in European competent authority databases are our routine work for many years. Documents are managed version controlled in a US CFR Part 11- compatible document – and submission- management system.Worldwide registration of Sigmapharm products

We maintain our own products in more than 50 countries in the European Union and worldwide.

Contact:
zulassung@sigmapharm.at
Tel: +43-(0)1-330 0671-0

 

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