Regulatory Submissions
We will help you prepare your regulatory submissions and transmit these to the regulatory agencies. We will proactively follow them up, identifying and responding to questions and issues as they arise.
Examples of some regulatory submissions with which we can help you here in Europe are listed below.
- Clinical trials applications (CTAs) - We will help you prepare the investigational medicinal product dossier (IMPD) and submit this to the national authorities, dealing with any questions that may arise from the assessment as required.
- Marketing authorisation applications (MAAs) - We will help you prepare your marketing authorisation applications in accordance with current requirements, including in electronic form. Submission processes include Centralised, Decentralised (DCP), Mutual Recognition (MRP) as well as national applications. Although our primary focus is on submissions to European regulatory agencies, we can also help you with submissions to other agencies outside Europe.
- Orphan medicinal products (OMPs) - We will help you prepare and submit applications to the EMA for orphan medicinal product status.
If you would like help with any regulatory submissions, or would like further information, please contact us.