Regulatory Services
Qeen Biotechnologies offers specialized regulatory consulting services for bacteriophage products, helping you navigate the complex regulatory landscape for phage therapies in Canada (Health Canada), the United-States (FDA), Europe (EMA), and UK (MHRA).
We assist in preparing comprehensive Chemistry, Manufacturing, and Controls (CMC) packages for bacteriophage products.
Our experts provide specialized consultation for Investigational New Drug (IND) applications related to bacteriophage therapy and regulatory applications worldwide.
We offer support in preparing compliant eCTD submissions for bacteriophage products, including:
- Document preparation and formatting
- Data management
- Submission management
By leveraging Qeen Biotechnologies’ regulatory services, you can streamline your path to regulatory approval for innovative bacteriophage products.