Registration of pharmaceutical substance

InfoLex provides services for registration of pharmaceutical ingredients:

• Evaluation of primary dossier;
• Request for missing documents (if necessary) according to 61 law;
• Preparation of registration documents;
• Translation of documents (if necessary);
• Preparation of ND/manufacturer’s monograph, artworks;
• Assembling and compilation registration dossier;
• Submission to the Ministry of Health;
• Submission of samples for pharmaceutical evaluation;
• Support of evaluation;
• Inclusion of the substance into the state register.

Our company will help you include the substance into the register or will advise on the documents to be requested from the manufacturer of the pharmaceutical ingredient used in your product.