Drug registration

As part of our services, we realize both the registration processes at all levels and all administrative services, including professional translations of summary of product characteristics, patient information leaflets, labelling, etc. We can ensure registration services as a single task but we are able to take over a complete registration agenda of a company in the long-term perspective including drugs, medical devices, food supplements and cosmetics. Furthermore, we can provide external professional consultation service according to the wishes of our clients.

We register

• Original drugs and generics
• Medical devices
• Food supplements
• Cosmetics

Medicinal products

•  Registration agenda
    - new registrations (national, DCP, MRP), variations of registrations, renewals, etc.
• Preparing of artworks (mock-ups) for labelling and patient information leaflets
• Translations (SmPC, PILs, labelling),
  - including the linguist proofreading according to the local requirements, terminology and local requirements for labelling
• Administration
  - ensuring your e-mail and postal correspondence between the SÚKL and the MAH, ensuring payment of registration fees, ensuring the position of the contact person for communication with the SÚKL

Food supplement and medical devices

• registration administration, contact with the MoH, State Health Institute, Chief Hygienist of the Czech Republic 

Pharmacovigilance

 

Pharma Product Management:
"We can fully and individually adapt ourselves to the client's needs. Our regulators have a long-term experience with registrations of original and generic drugs in the Czech market and EU. As one of a few companies in the Czech market we can ensure registrations of medicinal products, food supplements and cosmetics."