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Regulatory Affairs

Vizera helps you make the right decisions on how to register your product in the EU

Each category brings different opportunities for your product:

  • Medicines (Rx and OTC)
  • Medical devices
  • Food supplements 
  • Food for special medical purposes

We offer:

  • Compilation of documentation for health authorities
  • Submission of marketing authorisation applications for medicines
  • Registration of medical devices
  • Submission of relevant documents for food supplements and food for special medical purposes
  • Communication with health authorities
  • Preparation of product information in accordance with EU and national legislation (SmPC, PIL, labelling)
  • Lifecycle management
  • Regulatory consulting
  • Regulatory support for product development

Success can only be ensured as a result of well-thought-out procedures which are supported with carefully prepared documentation.

Clinical trials

Clinical Trials

Vizera has a wealth of experience in clinical trials of pharmaceuticals and nutraceuticals and provides support with EFSA claim submission. We are highly skilled in several therapeutic areas, some of which include gastroenterology, cognitive functions, paediatric health, and the immune and cardiovascular systems.

Research and development

Research and Development

Vizera’s project managers and experts work in a wide range of product development areas and are completely focused on achieving their goals regarding the development of pharmaceutical and nutraceutical products – from the initial concept right through to registration.

Business Enquiry

If you are interested in finding out more about regulatory affairs, you are kindly invited to complete the enquiry form below or send us an e-mail. All information you provide will be kept strictly confidential.

1.First name *
2.Surname *
3.E-mail *
4.Telephone *
5.Company name *
6.What type is your product?
7.What is the type of service?
8.When would you like to start with the project?
9.Is there anything else you would like to share with us?