Registration of medicinal products

InfoLex proposes high-quality consulting services for registration and introduction of amendments into registration documents for medicinal products and pharmaceutical ingredients, veterinary products in the territory of the RF and countries of the Customs Union.

Our specialists will save your time and money efficiently performing the complex of works or proposing individual services:

• preparation of registration dossier
• development of normative documents (ND/manufacturer’s monograph)
• development of patient information leaflet
• import of samples
• performance of pharmaceutical evaluation
• performance of nonclinical and clinical studies
• registration and legal support
• obtaining marketing authorization
• translation of medical text
• introduction of amendments into the documents, etc.
• certification of veterinary product.

InfoLex provides consultations and helps in respect of forming registration dossier for medicinal products and pharmaceutical ingredients.

• 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.
• Creation of registration dossier ready to be submitted to the Ministry of Health of the Russian Federation

If you have any questions, do not hesitate to contact us. Our company will help you register a medicinal product and determine what documents should be requested from the manufacturer.