Registration procedure required to release the products to market is a complex, expensive, and time consuming process. Registration managers of KM Universe provide professional “turnkey” assistance in registration of medicinal products in Ukraine. We are aware of any particularities of pharmaceutical market regulation in Ukraine. We represent the customer in the regulatory bodies, relying on the existing laws, until the full and successful completion of the registration (re-registration) of medicinal products.

Our professionals will prepare a master dossier in accordance with the laws, will present it to controlling bodies and ensure the complete monitor of the process up to the issuance of the registration certificate to your company.

AREAS OF OUR WORK:

  •  registration of medicines;
  •  re-registration of medicines;
  •  registration / re-registration of dietary supplements for a special diet;
  •  monitoring, analysis and advice on the legal framework of medicines registration in Ukraine.

SERVICES LIST:

  • obtaining original documents from the manufacturer;
  • translation of documents into Ukrainian or Russian, notarization of documents;
  • preparation of documents in accordance with the requirements of Ukrainian registration authorities;
  • filing with the State Pharmacological Committee of Ukraine for registration of medicines and documents delivery;
  • informing about the process of medicines registration in Ukraine;
  • coordination of the registration process, including settling current issues with regulators;
  • obtaining a certificate of registration of medicines;
  • registration of changes made by the company during the term of the registration certificate;
  • re-registration of the medicines (every five years).

We minimize the effort and time of our clients – we take over the bureaucratic and legal procedures and settle them quickly, efficiently, and reliably. To learn more about the service or order it, please contact us using the contacts provided.