Registration is the first step in pharmaceutical drug and medical device marketing and a key area of expertise within Cromos Pharma.

Сromos Pharma team has the necessary experience and provides a wide range of services related to the registration of medicinal products and medical devices not only in the United States, but also in the countries of Central and Eastern Europe, including the following:

  • Preliminary and gap analysis of submitted documentation
  • Preparation of registration dossier (CTD format for medical product)
  • Changes to registration certificate
  • Development of normative documentation
  • Notarization of regulatory documents in accordance with national legislation across several jurisdictions
  • Development of technical and operational documentation (for registration of medical devices)
  • Translation of all necessary medical documents
  • Submission of registration dossier to the regulatory authorities

Our Regulatory Affairs Department provides comprehensive services related to the registration of medicinal products and medical devices in an efficient, timely and cost-effective manner, coordinated in accordance with all applicable local regulatory requirements of the country of interest as required by the Client.

To learn more about our expertise and services registration activities, please contact our Business Development team.