Consultation on dossier formation

InfoLex provides consultations and helps in respect of forming registration dossier for medicinal products, pharmaceutical ingredients, veterinary products, medical devices, nutritional supplements.

  • Preparation, verification and presentation of such main documents as normative document (ND) and patient information leaflet (PIL).
  • Provision of list of documents necessary to prepare registration dossier.
  • Verification of all documents submitted, if necessary, translation.
  • Design of artworks.
  • Provision of registration dossier ready to be submitted to the Ministry of Health of the Russian Federation, Roszdravnadzor, Rospotrebnadzor, evaluation centers in dependence on the product being registered.

If you have any questions, do not hesitate to contact us.