Registration of Drug Products

ALPHALEK’s staff has a great experience in the practice of drug products registration. We offer our support to pharmaceutical companies for the drug products registration in the territory of the Republic of Belarus and the Eurasian Economic Union.

OUR SERVICES:

• Preparation of dossiers for submission to regulatory authorities
• Checking for documents compliance with the requirement of the Ministry of Health
• Submission of dossier and following-up of all registration steps
• Importation of samples for the quality control of drug products
• Receipt of marketing authorization and its transfer to the Customer

In the Republic of Belarus, experts of our company have registered more than 30 drug products and got favorable decisions on changes introduction in registration dossiers of more than 55 drug preparations.