klick regulatory

KLICK

quality

Adding value to our client's

product registrations.

regulatory and innovation

Providing regulatory services is one of the cornerstones of our business. Together with our partners, we provide our expertise across all kinds of activities and projects in the fields of development, approval and certification, as well as dossier management for pharmaceuticals. We can assess, update and manage your documentation and submit it for approval in Europe. If you prefer to purchase an existing MA or Dossier, we are on-hand to guide you through the process of obtaining licenses and dossiers including due diligence.

Regulatory success is affected by many variables. The key is having detailed knowledge of relevant legislation, ordinances, guidelines and other regulations. KLICK Quality will discuss all options for your product and prepare cost proposals for different scenarios. With our experts, we will assist you in preparing the necessary documents for CTD dossier; we will arrange the expert-reports and the application for approval. During the whole application process, we will accompany you and our team will help you with the communication with the authority.

In cooperation with different universities and other industry institutions, KLICK Quality serves the pharmaceutical community with a dedication to client satisfaction.